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Phase II Pilot Evaluation of Infusional 8 Cl-cAMP in the Treatment of Relapsed or Refractory Multiple Myeloma


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

Phase II Pilot Evaluation of Infusional 8 Cl-cAMP in the Treatment of Relapsed or Refractory Multiple Myeloma


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.

Inclusion 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)

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ann Traynor, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU FDA97H4

NCT ID:

NCT00004902

Start Date:

January 1998

Completion Date:

November 1999

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611