Thalidomide and Dacarbazine for Metastatic Melanoma

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Primary Purpose

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

thalidomide

dacarbazine

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with metastatic melanoma. Lesions must be measurable. Patient must have the following minimum labs: ANC> 1500/mm3, Hemoglobin > 8 mg/dl; platelets > 100,000 mm3; and liver function tests < 5x normal; and creatinine < 1.5 mg/dl. ECOG performance status > 2. No prior therapy with DTIC or thalidomide No other history of malignancy other than curatively resected basal cell carcinoma of the skin or carcinoma in situ of the cervix. Patients must not be pregnant or lactating. Sexually active men and women of childbearing age must use adequate contraception. All patients must understand the potential for severe birth defects with thalidomide and must be able to follow instructions to avoid conception while taking thalidomide

Sites / Locations

Kaplan Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00006200

First Posted

September 9, 2000

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

1. Study Identification

Unique Protocol Identification Number

NCT00006200

Brief Title

Thalidomide and Dacarbazine for Metastatic Melanoma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2004

Overall Recruitment Status

Unknown status

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

4. Oversight

5. Study Description

Brief Summary

The purpose of this clinical trial is to assess the activity of thalidomide in combination with dacarbazine (DTIC) in patients with metastatic melanoma. Safety and toxicity of the two drugs will also be assessed. Dacarbazine is the standard medical treatment for metastatic melanoma. It has been shown to produce tumor shrinkage in approximately 20% of patients with advanced melanoma. This shrinkage is usually incomplete and lasts a short time. Thalidomide is a drug that inhibits tumor blood vessel growth. It can be given orally. It is hoped that this combination can be given to patients with metastatic melanoma without causing too much toxicity while increasing the response rate.

6. Conditions and Keywords

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

Melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

thalidomide

Intervention Type

Drug

Intervention Name(s)

dacarbazine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Patients with metastatic melanoma. Lesions must be measurable. Patient must have the following minimum labs: ANC> 1500/mm3, Hemoglobin > 8 mg/dl; platelets > 100,000 mm3; and liver function tests < 5x normal; and creatinine < 1.5 mg/dl. ECOG performance status > 2. No prior therapy with DTIC or thalidomide No other history of malignancy other than curatively resected basal cell carcinoma of the skin or carcinoma in situ of the cervix. Patients must not be pregnant or lactating. Sexually active men and women of childbearing age must use adequate contraception. All patients must understand the potential for severe birth defects with thalidomide and must be able to follow instructions to avoid conception while taking thalidomide

Facility Information:

Facility Name

Kaplan Comprehensive Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Melanoma

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