Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Metastatic Melanoma

Back to results

Primary Purpose

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

filgrastim

busulfan

cyclophosphamide

cyclosporine

methotrexate

allogeneic bone marrow transplantation

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma

Eligibility Criteria

16 Years - 44 Years (Child, Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Biopsy proven relapsed malignant melanoma that has failed prior standard regimen for metastatic disease Must have HLA-matched or related bone marrow donor (5- or 6-antigen match) No history of CNS metastases PATIENT CHARACTERISTICS: Age: 16 to 44 Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: SGOT and SGPT less than 1.5 times upper limit of normal Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL AND/OR Creatinine clearance greater than 75 mL/min Cardiovascular: No history of cardiac disease No symptomatic cardiac disease Ejection fraction greater than 50% Pulmonary: FEV1 greater than 50% predicted (greater than 75% if received thoracic irradiation) DLCO greater than 50% predicted Other: Not pregnant Fertile women must use effective contraception HIV negative No active bacterial, fungal, or viral infection Hepatitis B negative PRIOR CONCURRENT THERAPY: At least 1 prior standard regimen for metastatic disease

Sites / Locations

Louisiana State University School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00003060

First Posted

November 1, 1999

Last Updated

June 26, 2020

Sponsor

Louisiana State University Health Sciences Center Shreveport

1. Study Identification

Unique Protocol Identification Number

NCT00003060

Brief Title

Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Metastatic Melanoma

Official Title

Pilot Study for Matched-Related Allogeneic Bone Marrow Transplantation for Metastatic Malignant Melanoma

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Terminated

Why Stopped

lack of patient accrual

Study Start Date

March 1995 (undefined)

Primary Completion Date

February 22, 2001 (Actual)

Study Completion Date

February 22, 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Louisiana State University Health Sciences Center Shreveport

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Clinical trial to study the effectiveness of chemotherapy plus bone marrow transplantation in treating patients with metastatic melanoma that has not responded to previous therapy.

Detailed Description

OBJECTIVES: I. Determine the response rate and survival of patients with metastatic malignant melanoma who have failed first-line therapy when treated with match-related allogeneic bone marrow transplantation. OUTLINE: This is a pilot study. Patients receive a preparative regimen of busulfan and cyclophosphamide. Busulfan PO is administered every 6 hours on days -7 to -4. Cyclophosphamide IV is administered on days -3 to -2 followed by one day of rest. Bone marrow infusion occurs on day 0. Cyclosporine begins on day -1 and continues until day 180. Methotrexate IV is administered on days 1, 3, 6, and 11. Granulocyte colony-stimulating factor is administered as a continuous IV every 2 hours starting on day 12 and continuing until absolute neutrophil count is greater than 1,000 g/dL for 2 consecutive days. Patients receive weekly follow up for the first 180 days and monthly thereafter. Patients are followed until death. PROJECTED ACCRUAL: 6 patients with melanoma will be accrued.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma (Skin)

Keywords

recurrent melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Enrollment

6 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

filgrastim

Intervention Type

Drug

Intervention Name(s)

busulfan

Intervention Type

Drug

Intervention Name(s)

cyclophosphamide

Intervention Type

Drug

Intervention Name(s)

cyclosporine

Intervention Type

Drug

Intervention Name(s)

methotrexate

Intervention Type

Procedure

Intervention Name(s)

allogeneic bone marrow transplantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

44 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Biopsy proven relapsed malignant melanoma that has failed prior standard regimen for metastatic disease Must have HLA-matched or related bone marrow donor (5- or 6-antigen match) No history of CNS metastases PATIENT CHARACTERISTICS: Age: 16 to 44 Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: SGOT and SGPT less than 1.5 times upper limit of normal Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL AND/OR Creatinine clearance greater than 75 mL/min Cardiovascular: No history of cardiac disease No symptomatic cardiac disease Ejection fraction greater than 50% Pulmonary: FEV1 greater than 50% predicted (greater than 75% if received thoracic irradiation) DLCO greater than 50% predicted Other: Not pregnant Fertile women must use effective contraception HIV negative No active bacterial, fungal, or viral infection Hepatitis B negative PRIOR CONCURRENT THERAPY: At least 1 prior standard regimen for metastatic disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benjamin B. Weinberger, MD

Organizational Affiliation

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

Official's Role

Study Chair

Facility Information:

Facility Name

Louisiana State University School of Medicine

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71130-3932

Country

United States

Melanoma (Skin)

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial