Interleukin-2 in Treating Patients With Metastatic Melanoma

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Primary Purpose

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

aldesleukin

About this trial

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

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven melanoma that is metastatic No tumor replacement of 25% or more of liver on CT or MRI No involvement of the CNS or a major nerve Measurable disease required PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80%-100% Life expectancy: More than 3 months Hematopoietic: No coagulopathy (i.e., platelets less than 80,000) Hepatic: Bilirubin normal Renal: Creatinine normal Cardiovascular: No abnormal cardiac stress test in patients over 50 years of age or with possible cardiac disease suggested by history, physical exam, or EKG Pulmonary: FEV1 or VC greater than 65% of predicted in patients with significant smoking history or with suspected pulmonary disease by history, physical exam, or x-ray Other: No site of ongoing bleeding No systemic infection No HIV antibody No HBsAg No requirement for steroids No psychiatric disease that precludes informed consent or protocol treatment No second malignancy except: Basal cell skin carcinoma Carcinoma in situ of the cervix No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: No prior interleukin-2 At least 28 days since treatment for melanoma

Sites / Locations

Carolinas Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002845

First Posted

November 1, 1999

Last Updated

December 18, 2013

Sponsor

Blumenthal Cancer Center at Carolinas Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00002845

Brief Title

Interleukin-2 in Treating Patients With Metastatic Melanoma

Official Title

TREATMENT OF METASTATIC MELANOMA WITH RECOMBINANT INTERLEUKIN-2

Study Type

Interventional

2. Study Status

Record Verification Date

May 2000

Overall Recruitment Status

Unknown status

Study Start Date

September 1995 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Blumenthal Cancer Center at Carolinas Medical Center

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients who have metastatic melanoma.

Detailed Description

OBJECTIVES: I. Evaluate the response and survival rates of patients with metastatic melanoma following induction with high-dose and maintenance with low-dose interleukin-2. II. Assess the toxicity of this regimen. OUTLINE: All patients receive high-dose interleukin-2 over 24 hours, followed by low-dose interleukin-2 for 4 days in the absence of toxicity. Patients receive a second cycle beginning 9-13 days after completion of the first cycle, with response assessed approximately 2 months after initiating therapy. Patients with stable or responding disease receive a second course as above; those with a continued response may receive additional courses provided toxicity is limited. Patients are followed for survival. PROJECTED ACCRUAL: 20 patients will be entered.

6. Conditions and Keywords

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

Melanoma (Skin)

Keywords

stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

aldesleukin

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically proven melanoma that is metastatic No tumor replacement of 25% or more of liver on CT or MRI No involvement of the CNS or a major nerve Measurable disease required PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80%-100% Life expectancy: More than 3 months Hematopoietic: No coagulopathy (i.e., platelets less than 80,000) Hepatic: Bilirubin normal Renal: Creatinine normal Cardiovascular: No abnormal cardiac stress test in patients over 50 years of age or with possible cardiac disease suggested by history, physical exam, or EKG Pulmonary: FEV1 or VC greater than 65% of predicted in patients with significant smoking history or with suspected pulmonary disease by history, physical exam, or x-ray Other: No site of ongoing bleeding No systemic infection No HIV antibody No HBsAg No requirement for steroids No psychiatric disease that precludes informed consent or protocol treatment No second malignancy except: Basal cell skin carcinoma Carcinoma in situ of the cervix No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: No prior interleukin-2 At least 28 days since treatment for melanoma

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard L. White, MD

Organizational Affiliation

Blumenthal Cancer Center at Carolinas Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

Carolinas Medical Center

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28232-2861

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