- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00089271
17-DMAG in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphomas
A Phase I Study Of 17-Dimethylaminoethylamino-17-Demethoxygeldanamycin, (17-DMAG) (NSC 707545) In Patients With Advanced Solid Tumors
Study Overview
Status
Conditions
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Nodal Marginal Zone B-cell Lymphoma
- Recurrent Adult Burkitt Lymphoma
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Diffuse Mixed Cell Lymphoma
- Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
- Recurrent Grade 1 Follicular Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Grade 3 Follicular Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Marginal Zone Lymphoma
- Splenic Marginal Zone Lymphoma
- Waldenström Macroglobulinemia
- Unspecified Adult Solid Tumor, Protocol Specific
- Anaplastic Large Cell Lymphoma
- Angioimmunoblastic T-cell Lymphoma
- Intraocular Lymphoma
- Recurrent Adult Hodgkin Lymphoma
- Recurrent Adult T-cell Leukemia/Lymphoma
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
- Recurrent Mycosis Fungoides/Sezary Syndrome
- Recurrent Small Lymphocytic Lymphoma
- Stage III Adult Burkitt Lymphoma
- Stage III Adult Diffuse Large Cell Lymphoma
- Stage III Adult Diffuse Mixed Cell Lymphoma
- Stage III Adult Diffuse Small Cleaved Cell Lymphoma
- Stage III Adult Hodgkin Lymphoma
- Stage III Adult T-cell Leukemia/Lymphoma
- Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage III Grade 1 Follicular Lymphoma
- Stage III Grade 2 Follicular Lymphoma
- Stage III Grade 3 Follicular Lymphoma
- Stage III Mantle Cell Lymphoma
- Stage III Marginal Zone Lymphoma
- Stage III Mycosis Fungoides/Sezary Syndrome
- Stage III Small Lymphocytic Lymphoma
- Stage IV Adult Burkitt Lymphoma
- Stage IV Adult Diffuse Large Cell Lymphoma
- Stage IV Adult Diffuse Mixed Cell Lymphoma
- Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
- Stage IV Adult Hodgkin Lymphoma
- Stage IV Adult T-cell Leukemia/Lymphoma
- Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage IV Grade 1 Follicular Lymphoma
- Stage IV Grade 2 Follicular Lymphoma
- Stage IV Grade 3 Follicular Lymphoma
- Stage IV Mantle Cell Lymphoma
- Stage IV Marginal Zone Lymphoma
- Stage IV Mycosis Fungoides/Sezary Syndrome
- Stage IV Small Lymphocytic Lymphoma
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in patients with metastatic or unresectable solid tumors or lymphomas.
II. Determine the safety and toxicity of this drug in these patients. III. Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
IV. Determine the recommended phase II dose of this drug for future studies.
SECONDARY OBJECTIVES:
I. Determine tumor response in patients treated with this drug.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) IV over 1-6 hours on days 1-3 or 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-2 patients receive accelerated escalating doses of 17-DMAG until at least 1 of 2 patients experience dose-limiting toxicity (DLT). Cohorts are then expanded to 3-6 patients who receive escalating doses (in a standard manner) of 17-DMAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT.
Patients are followed at 4 weeks.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15232
- University of Pittsburgh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Histologically confirmed solid tumor or lymphoma
- Metastatic or unresectable disease
- Standard curative or palliative measures do not exist or are no longer effective
- No known brain metastases
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- More than 12 weeks
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
- ALT and AST ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ normal
- Creatinine ≤ 1.25 times ULN
- Creatinine clearance ≥ 60 mL/min
- QTc < 450 msec for male patients (470 msec for female patients)
- LVEF > 40% by MUGA
- No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- No myocardial infarction or active ischemic heart disease within the past year
- No New York Heart Association class III or IV congestive heart failure
- No poorly controlled angina
- No uncontrolled dysrhythmia requiring medication
- No left bundle branch block
- No history of congenital long QT syndrome
- No other significant cardiac disease
- Pulse oximetry at rest or on exercise > 88%
No symptomatic pulmonary disease (e.g., chronic obstructive or restrictive pulmonary disease, etc.) or any of the following are allowed:
- Pulmonary disease requiring medication
- History of dyspnea, dyspnea on exertion, or paroxysmal nocturnal dyspnea
- Patients meeting the Medicare criteria for home oxygen or are on oxygen
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double barrier contraception 1 week before, during, and for at least 2 weeks after study participation
- No uncontrolled illness
- No active or ongoing infection
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG)
- No psychiatric illness or social situation that would preclude study compliance
- No concurrent routine colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- Concurrent hormonal therapy allowed
- At least 4 weeks since prior radiotherapy and recovered
- No prior radiation that included the heart in the field (e.g., mantle)
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent anticancer agents or therapies
- No concurrent medication that would prolong the QTc interval
- No other concurrent investigational agents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (alvespimycin hydrochloride)
Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) IV over 1-6 hours on days 1-3 or 1-5.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose of alvespimycin hydrochloride
Time Frame: 21 days
|
21 days
|
|
Toxicity graded using the NCI CTCAE version 3.0
Time Frame: Up to 4 weeks
|
Up to 4 weeks
|
|
Recommended phase II dose (RP2D) of alvespimycin hydrochloride for future studies determined by toxicity assessments
Time Frame: 21 days
|
21 days
|
|
Pharmacokinetics of alvespimycin hydrochloride in blood, urine, and tumor tissue
Time Frame: 21 days
|
Analyzed by both non-compartmental and compartmental methods.
|
21 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tumor response assessed by tumor measurements
Time Frame: Up to 4 weeks
|
Up to 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chandra Belani, University of Pittsburgh
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Virus Diseases
- Infections
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Disease Attributes
- Disease
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- DNA Virus Infections
- Bacterial Infections and Mycoses
- Tumor Virus Infections
- Neoplasms, Plasma Cell
- Leukemia, Lymphoid
- Epstein-Barr Virus Infections
- Herpesviridae Infections
- Leukemia, B-Cell
- Eye Neoplasms
- Lymphadenopathy
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Syndrome
- Leukemia
- Hodgkin Disease
- Recurrence
- Lymphoma, Non-Hodgkin
- Mycoses
- Burkitt Lymphoma
- Lymphoma, Mantle-Cell
- Lymphoma, B-Cell, Marginal Zone
- Waldenstrom Macroglobulinemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
- Leukemia, T-Cell
- Leukemia-Lymphoma, Adult T-Cell
- Mycosis Fungoides
- Sezary Syndrome
- Lymphoma, Large-Cell, Anaplastic
- Intraocular Lymphoma
- Immunoblastic Lymphadenopathy
Other Study ID Numbers
- NCI-2012-02620
- PCI-03-153
- U01CA069912 (U.S. NIH Grant/Contract)
- U01CA099168 (U.S. NIH Grant/Contract)
- U01CA062502 (U.S. NIH Grant/Contract)
- CDR0000378189 (Registry Identifier: PDQ (Physician Data Query))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAnn Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Extranodal Marginal Zone LymphomaUnited States
-
University of WashingtonGenentech, Inc.RecruitingMarginal Zone Lymphoma | Non-Hodgkin Lymphoma | Grade 1 Follicular Lymphoma | Grade 2 Follicular Lymphoma | Grade 3a Follicular Lymphoma | Indolent B-Cell Non-Hodgkin Lymphoma | Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Refractory Extranodal Marginal Zone...United States
-
Narendranath EpperlaNot yet recruitingRecurrent Mantle Cell Lymphoma | Recurrent Marginal Zone Lymphoma | Refractory Mantle Cell Lymphoma | Refractory Marginal Zone Lymphoma | Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid... and other conditionsUnited States
-
University of WashingtonMillennium Pharmaceuticals, Inc.Active, not recruitingFollicular Lymphoma | Waldenstrom Macroglobulinemia | Mantle Cell Lymphoma | Marginal Zone Lymphoma | Chronic Lymphocytic Leukemia | Lymphoplasmacytic Lymphoma | Small Lymphocytic Lymphoma | Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Refractory Extranodal Marginal...United States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Genentech, Inc.; Pharmacyclics LLC.RecruitingNon-Hodgkin's Lymphoma | Indolent Non-hodgkin Lymphoma | Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Ann Arbor Stage II Follicular Lymphoma | Ann Arbor Stage II Nodal Marginal Zone Lymphoma | Ann Abor Stage III B-Cell Non-Hodgkin Lymphoma | Ann Arbor... and other conditionsUnited States
-
Yazeed SawalhaWithdrawnRecurrent Grade 1 Follicular Lymphoma | Recurrent Grade 2 Follicular Lymphoma | Recurrent Mantle Cell Lymphoma | Recurrent Marginal Zone Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent Grade 3a Follicular Lymphoma | Refractory Grade 1 Follicular... and other conditions
-
Robert LowskyNational Cancer Institute (NCI)CompletedExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Grade 1 Follicular Lymphoma | Recurrent Grade 2 Follicular Lymphoma | Recurrent Marginal Zone Lymphoma | Splenic Marginal Zone Lymphoma | Recurrent Small Lymphocytic...United States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedRecurrent Grade 1 Follicular Lymphoma | Recurrent Grade 2 Follicular Lymphoma | Recurrent Grade 3 Follicular Lymphoma | Recurrent Marginal Zone Lymphoma | Waldenstrom Macroglobulinemia | Refractory B-Cell Non-Hodgkin Lymphoma | Recurrent Small Lymphocytic Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma and other conditionsUnited States
-
Arbeitsgemeinschaft medikamentoese TumortherapieHoffmann-La Roche; LipomedCompletedLymphoma of Mucosa-Associated Lymphoid TissueAustria
-
National Cancer Institute (NCI)WithdrawnExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Grade 1 Follicular Lymphoma | Recurrent Grade 2 Follicular Lymphoma | Recurrent Mantle Cell Lymphoma | Recurrent Marginal Zone Lymphoma | Splenic Marginal Zone LymphomaUnited States
Clinical Trials on laboratory biomarker analysis
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingLeukemia | Acute Lymphoblastic Leukemia | Acute Promyelocytic LeukemiaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedUntreated Adult Acute Lymphoblastic Leukemia | Untreated Childhood Acute Lymphoblastic LeukemiaUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Lymphoblastic Leukemia in Remission | Recurrent Childhood Acute Lymphoblastic LeukemiaUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedLung CancerUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed
-
Children's Oncology GroupNational Cancer Institute (NCI)WithdrawnClear Cell Renal Cell Carcinoma | Rhabdoid Tumor of the Kidney | Congenital Mesoblastic Nephroma | Childhood Kidney NeoplasmUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)WithdrawnBreast Carcinoma | BRCA1 Mutation Carrier | BRCA2 Mutation CarrierUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedWilms Tumor and Other Childhood Kidney TumorsUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Monoblastic Leukemia (M5a) | Childhood Acute Monocytic Leukemia (M5b) | Childhood Acute Myeloblastic Leukemia Without Maturation (M1) | Childhood Acute Myelomonocytic Leukemia (M4) | Childhood Acute Myeloid Leukemia/Other Myeloid MalignanciesUnited States