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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2001 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00003490

First received: November 1, 1999

Last updated: February 6, 2009

Last verified: March 2001

History of Changes

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

February 6, 2009

Start Date ^ICMJE

October 1998

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00003490 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Phase II to Treat Multiple Myeloma Patients With Cytoxan and Vincristine After Cycling Myeloma Cells With rHuGM-CSF

Brief 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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Multiple Myeloma and Plasma Cell Neoplasm

Intervention ^ICMJE

Biological: sargramostim
Drug: cyclophosphamide
Drug: prednisone
Drug: vincristine sulfate

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00003490

Other Study ID Numbers ^ICMJE

CDR0000066529, CCF-IRB-1863, IMMUNEX-001.0743, NCI-V98-1458

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

The Cleveland Clinic

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Mohamad A. Hussein, MD

The Cleveland Clinic

Information Provided By

National Cancer Institute (NCI)

Verification Date

March 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top