- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00117988
17-AAG in Treating Patients With Relapsed or Refractory Anaplastic Large Cell Lymphoma, Mantle Cell Lymphoma, or Hodgkin's Lymphoma
A Phase II Study of 17-AAG in Patients With Relapsed/Refractory CD30+ Anaplastic Large Cell Lymphoma (ALCL), Relapsed/Refractory Mantle Cell Lymphoma (MCL), and Relapsed/Refractory Classical Hodgkin's Lymphoma (HL)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. Determine the complete and partial response rates and time to treatment failure in patients with relapsed or refractory anaplastic large cell lymphoma, mantle cell lymphoma, or classical Hodgkin's lymphoma treated with 17-N-allylamino-17-demethoxygeldanamycin (17-AAG).
SECONDARY OBJECTIVES:
I. Determine the safety of this drug in these patients. II. Determine the biologic effect of this drug on selected molecular targets in primary lymphoma cells from these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease type (anaplastic large cell lymphoma vs mantle cell lymphoma vs Hodgkin's lymphoma).
Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease regression after completion of 8 courses may receive 2 additional courses of treatment beyond their maximal response.
After completion of study treatment, patients are followed every 3 months until disease progression.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Negative pregnancy test
- Fertile patients must use effective contraception prior to and during study treatment
- Must have normal organ and marrow function
- Not a candidate for stem cell transplantation
- ECOG 0-2 OR Karnofsky 60-100%
- Bilirubin normal
- Creatinine normal
- Histologically or cytologically confirmed relapsed or refractory mantle cell lymphoma, anaplastic large cell lymphoma (CD30-positive disease), or classical Hodgkin's lymphoma
- Recovered from prior biologic therapy or autologous stem cell transplantation
- Prior antibody therapy within the past 3 months allowed
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- More than 4 weeks since prior radiotherapy (12 weeks for radioimmunotherapy) and recovered
- Recovered from prior investigational drugs
- Recovered from prior surgery
- More than 4 weeks since other prior anticancer therapy
- Concurrent low-molecular weight heparin is allowed
- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm
- Absolute neutrophil count >= 1,500/mm3
- Received >= 1, but =< 3, prior treatment regimens for lymphoma (salvage therapy followed immediately by stem cell transplantation is considered 1 regimen). Single-agent monoclonal antibody therapy, cytokine therapy, or involved field radiotherapy are not considered prior treatment regimens. All prior treatments and prior antibody therapy within the past 3 months are recorded.
- Platelet count >= 75,000/mm3
- AST and ALT =< 1.5 times upper limit of normal
- Understand and provide signed informed consent.
Exclusion Criteria:
- No cardiac arrhythmia or uncontrolled dysrhythmia
- No history of myocardial infarction within the past year
- No New York Heart Association class III or IV heart failure
- No other significant cardiac disease
- No paroxysmal nocturnal dyspnea
- No oxygen requirement
- No AIDS
- No history cardiac toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubcin hydrochloride, mitoxantrone, bleomycin, or carmustine)
- No pulmonary lymphoma
- No known CNS lymphoma
- QTc >/= 450 msec for men
- QTc >/= 470 msec for women
- LVEF </= 40% by MUGA
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No symptomatic pulmonary disease requiring medication
- No significant pulmonary disease including chronic obstructive or restrictive pulmonary disease
- No dyspnea on or off exertion
- No history of pulmonary toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubcin hydrochloride, mitoxantrone, bleomycin, or carmustine)
- Not pregnant or nursing
- No other uncontrolled illness
- No other active* malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No prior allogeneic stem cell transplantation
- No history of allergic reaction to eggs
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No prior chest radiation or prior radiation that potentially included the heart in the field (e.g.,mantle).
- No concurrent medications that prolong or may prolong QTc
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational agents
- No other concurrent anticancer therapy
- No prior cardiac symptoms >= grade 2
- No sufficiently compromised pulmonary status (i.e., DLCO =< 80%)
- No history of serious ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation >= 3 beats in a row)
- No prior pulmonary symptoms >= grade 2
- HIV negative
- No active ischemic heart disease within 12 months.
- No congenital long QT syndrome.
- No left bundle branch block.
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: Arm I
Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 4, 8, and 11.
Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients experiencing disease regression after completion of 8 courses may receive 2 additional courses of treatment beyond their maximal response.
After completion of study treatment, patients are followed every 3 months until disease progression.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With Response
Time Frame: Baseline to time to best response; Every 6 weeks
|
Number of participants who experience complete response or partial response.
Partial Response=>50% decrease in lympho node masses.
Complete Response=>-75% decrease in lymph node masses.
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Baseline to time to best response; Every 6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anas Younes, M.D. Anderson Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
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
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease Attributes
- Lymphoma, T-Cell
- Lymphoma
- Hodgkin Disease
- Recurrence
- Lymphoma, Non-Hodgkin
- Lymphoma, Mantle-Cell
- Lymphoma, Large-Cell, Anaplastic
Other Study ID Numbers
- NCI-2009-00101 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- P30CA016672 (U.S. NIH Grant/Contract)
- CDR0000433593
- 2004-0792 (Other Identifier: M D Anderson Cancer Center)
- 6936 (Other Identifier: CTEP)
- R21CA117070 (U.S. NIH Grant/Contract)
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.
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