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 8-chloro-cyclic adenosine monophosphate in treating patients who have recurrent or refractory multiple myeloma.

Condition	Treatment or Intervention	Phase
stage II multiple myeloma stage III multiple myeloma stage I multiple myeloma refractory plasma cell neoplasm	Drug: -chloro-cyclic adenosine monophosphate	Phase II

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--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)

--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

--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

Illinois
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611,  United States

Study chairs or principal investigators

Ann Traynor,  Study Chair,  Robert H. Lurie Cancer Center   

Study ID Numbers:  CDR0000067581; NU-97H4; NCI-G00-1681
Record last reviewed:  July 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004902
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-20