Overview

Combination Chemotherapy Following GM-CSF in Treating Patients With Multiple Myeloma

Status:
Completed
Trial end date:
2003-08-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. GM-CSF may make cancer cells more sensitive to the effects of chemotherapy. Combining more than one drug with GM-CSF may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, consisting of cyclophosphamide plus vincristine, following GM-CSF in treating patients with multiple myeloma that has not responded to previous treatment.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Cleveland Clinic
Treatments:
Cyclophosphamide
Prednisone
Sargramostim
Vincristine
Criteria
DISEASE CHARACTERISTICS: Histologically proven multiple myeloma Pancytopenia related to
multiple myeloma allowed Failed or progressed after at least 2 chemotherapy or biologic
therapy regimens

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Platelet count at least 50,000/mm3 Absolute
neutrophil count at least 750/mm3 Hepatic: SGOT/SGPT less than 3 times upper limit of
normal Bilirubin less than 5.0 mg/dL Renal: Not specified Other: No active infection
requiring intravenous antibiotics Not HIV positive Not pregnant or nursing Fertile patients
must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics May have failed
prior bone marrow transplant No other concurrent colony stimulating factors Concurrent
immunoglobulin allowed Chemotherapy: See Disease Characteristics Concurrent pamidronate
allowed Endocrine therapy: Not specified Radiotherapy: Concurrent standard radiation
therapy to treat extra-skeletal and/or skeletal tumor sites allowed Surgery: Not specified
Other: Concurrent epoetin alfa for anemia allowed