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. ELIGIBILITY

At lest 16 years old

Condition	Treatment or Intervention	Phase
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma refractory plasma cell neoplasm	Drug: cyclophosphamide  Drug: prednisone  Drug: sargramostim  Drug: vincristine	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the response rate of multiple myeloma patients when treated with cyclophosphamide and vincristine after cycling myeloma cells with sargramostim (GM-CSF). II. Evaluate whether Labelling Index (LI) changes influenced by GM-CSF would predict a group of patients that will respond to this particular course specific design. III. Determine the toxicity of GM-CSF in these patients.

PROTOCOL OUTLINE: Patients receive subcutaneous injections of sargramostim (GM-CSF) once a day for 5 days. Two to 3 days later, patients receive cyclophosphamide IV over 30-45 minutes on day 1, vincristine IV bolus on day 8, and oral prednisone 4 times a day on days 1-4. Patients also receive subcutaneous injections of GM-CSF starting on day 2 and continuing for 10 days or until neutrophil count is at least 1000/mm3. Treatment continues every 3 weeks for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve at least stable response receive GM-CSF 3 times a week for up to 2 years. Patients are followed every 3-6 months.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued.

Ages Eligible for Study:  16 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

Ohio
      Cleveland Clinic Cancer Center, Cleveland,  Ohio,  44195,  United States

Study chairs or principal investigators

Mohamad Ahmed Hussein,  Study Chair,  Cleveland Clinic Foundation Hospital   

Study ID Numbers:  CDR0000066529; CCF-IRB-1863; NCI-V98-1458; IMMUNEX-001.0743
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003490
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08