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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003490
First received: November 1, 1999
Last updated: December 3, 2013
Last verified: March 2001
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Biological: sargramostim
Drug: cyclophosphamide
Drug: prednisone
Drug: vincristine sulfate
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II to Treat Multiple Myeloma Patients With Cytoxan and Vincristine After Cycling Myeloma Cells With rHuGM-CSF

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 30
Study Start Date: October 1998
Study Completion Date: August 2003
Detailed Description:

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.

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00003490

Locations
United States, Ohio
Cleveland Clinic Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Study Chair: Mohamad A. Hussein, MD The Cleveland Clinic
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003490     History of Changes
Other Study ID Numbers: CDR0000066529, CCF-IRB-1863, IMMUNEX-001.0743, NCI-V98-1458
Study First Received: November 1, 1999
Last Updated: December 3, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Prednisone
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Glucocorticoids

ClinicalTrials.gov processed this record on July 22, 2014