Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma

NCT00004141 | Completed Phase 2

• 4 other identifiers: 9372UCCRC-9372UCCRC-CTRC-9821NCI-G99-1615
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cell from growing. Combining more than one drug with different types of biological therapies may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus biological therapy in treating patients who have metastatic melanoma.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  2 years

Study Arms (1)

Arm A

EXPERIMENTAL

CDDP (75 mg/m2) and DTIC (660 mg/m2) will be administered sequentially by intravenous infusion in day 1. Subsequently, GM-CSF (450 mg/ m2) will be administered SC days 2-7; IL-2 (11 MU daily) will be given SC days 8-14, and IFN-2b (9 MU) will be given SC days 8, 10, 12, and 14.

Drug: Cisplatin; Drug: dacarbazine; Drug: Granulocyte-macrophage colony-stimulating factor

Interventions

Cisplatin DRUG

Also known as: CDDP

Arm A

dacarbazine DRUG

Also known as: DTIC

Arm A

Granulocyte-macrophage colony-stimulating factor DRUG

Also known as: GM-CSF

Arm A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic melanoma * Stage III with intransit metastases * Stage IV * No uncontrolled brain metastases by CT scan * No clinically significant ascites or pleural effusions PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Karnofsky 70-100% Life expectancy: * At least 10 weeks Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9.5 g/dL Hepatic: * Bilirubin no greater than 2.0 mg/dL * SGOT no greater than 4 times upper limit of normal Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 70 mL/min Cardiovascular: * No clinically significant cardiac disease on EKG, echocardiogram, or MUGA scan Pulmonary: * No clinically significant pulmonary disease on chest x-ray Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No significant thyroid dysfunction * No concurrent severe infection * No other medical or psychiatric condition that would interfere with compliance * No second malignancy within the past 5 years, except: * Localized nonmelanomatous skin cancer * Carcinoma in situ of the cervix * Grade 1 Ta bladder cancer * Suspected hearing deficits must undergo audiologic testing PRIOR CONCURRENT THERAPY: Biologic therapy: * No more than one prior immunotherapy regimen * At least 4 weeks since prior immunotherapy * Adjuvant interferon alfa before relapse allowed Chemotherapy: * No more than one prior chemotherapy regimen * At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) * No concurrent cyclophosphamide * No other concurrent chemotherapy Endocrine therapy: * No concurrent corticosteroids or cyclosporine A Radiotherapy: * At least 2 weeks since prior radiotherapy Surgery: * At least 3 weeks since major surgery Other: * No concurrent immunosuppressive drugs * No other concurrent investigational antineoplastic drugs * Concurrent thyroid replacement therapy allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Cisplatin; Dacarbazine; Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Thomas F. Gajewski, MD, PhD

  University of Chicago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 1999
• First Posted: January 27, 2003
• Study Start: August 1, 1998
• Primary Completion: January 1, 2003
• Study Completion: April 1, 2006
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

US (1)