- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004902
Tocladesine in Treating Patients With Recurrent or Refractory Multiple Myeloma
Phase II Pilot Evaluation of Infusional 8 Cl-cAMP in the Treatment of Relapsed or Refractory Multiple Myeloma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of tocladesine in treating patients who have recurrent or refractory multiple myeloma.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Determine the safety of 8-chloro-cyclic adenosine monophosphate (8-chloro-cAMP) in patients with recurrent or refractory multiple myeloma. II. Evaluate the efficacy of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: Patients receive 8-chloro-cyclic adenosine monophosphate (8-chloro-cAMP) over 120 hours every 2 weeks for up to 4 courses. Beginning with course 5, patients with stable or responsive disease receive 8-chloro-cAMP over 120 hours every 3 weeks until disease progression. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A maximum of 29 patients will be accrued for this study within 12-18 months.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent or refractory multiple myeloma Measurable disease by monoclonal serum or urine globulins OR Malignant plasma cells documented on bilateral bone marrow biopsy Refractory after at least one prior therapeutic regimen (no more than 2 prior regimens allowed)
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine no greater than 1.5 mg/dL AND/OR Creatinine clearance at least 60 mL/min Calcium no greater than 8.7 g/dL Cardiovascular: No history of arrhythmias No uncontrolled angina pectoris No symptomatic coronary ischemia No grade 3 or 4 congestive heart failure Cardiac ejection fraction greater than 35% by gated imaging Other: Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy Endocrine therapy: At least 3 weeks since prior glucocorticoids Radiotherapy: Not specified Surgery: Not specified Other: No concurrent theophylline therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Ann Traynor, MD, Robert H. Lurie 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
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- 8-chloro-cyclic adenosine monophosphate
Other Study ID Numbers
- NU FDA97H4
- NU-97H4
- NCI-G00-1681
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 Multiple Myeloma and Plasma Cell Neoplasm
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The Cleveland ClinicWithdrawnStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Plasma Cell NeoplasmUnited States
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OncotherapeuticsWithdrawnStage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Plasma Cell NeoplasmUnited States
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National Cancer Institute (NCI)CompletedStage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Plasma Cell NeoplasmUnited States
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Medical Research CouncilUnknownMultiple Myeloma and Plasma Cell NeoplasmUnited Kingdom
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Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)CompletedMultiple Myeloma and Plasma Cell NeoplasmUnited States
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Jonsson Comprehensive Cancer CenterMillennium Pharmaceuticals, Inc.CompletedMultiple Myeloma and Plasma Cell NeoplasmUnited States
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University of Maryland, BaltimoreCompletedMultiple Myeloma and Plasma Cell NeoplasmUnited States
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Masonic Cancer Center, University of MinnesotaTerminatedMultiple Myeloma and Plasma Cell NeoplasmUnited States
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Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)TerminatedMultiple Myeloma and Plasma Cell NeoplasmUnited States
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National Cancer Institute (NCI)CompletedDexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple MyelomaMultiple Myeloma and Plasma Cell NeoplasmUnited States, Puerto Rico, South Africa
Clinical Trials on tocladesine
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