NCT00014092

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interleukin-2 and interferon alfa stimulate a person's white blood cells to kill cancer cells or may interfere with the growth of cancer cells. Combining chemotherapy with biological therapies may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by sargramostim, interleukin-2, and interferon alfa in treating patients who have stage IV melanoma that cannot be treated with surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 1999

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2001

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
Last Updated

March 26, 2013

Status Verified

March 1, 2004

First QC Date

April 10, 2001

Last Update Submit

March 25, 2013

Conditions

Melanoma (Skin)

Keywords

stage IV melanomarecurrent melanoma

Interventions

aldesleukinBIOLOGICAL
recombinant interferon alfaBIOLOGICAL
sargramostimBIOLOGICAL
temozolomideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed unresectable stage IV melanoma * Measurable metastatic disease * No uncontrolled brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * More than 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT and SGPT no greater than 3 times ULN * Alkaline phosphatase no greater than 3 times ULN Renal: * BUN no greater than 1.5 times ULN * Creatinine no greater than 1.5 times ULN Cardiovascular: * No significant cardiovascular disease Other: * No non-malignant systemic disease * No acute infection requiring IV antibiotics * No alcohol or substance abuse * No other condition, disease, or history of other illness that would preclude study participation * No hypersensitivity, allergic reactions, or intolerance to study drugs * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy * No prior interleukin-2 * No other concurrent immunotherapy * No concurrent investigational vaccines or immunomodulatory agents * No other concurrent growth factors Chemotherapy: * At least 4 weeks since prior chemotherapy * No prior temozolomide * No other concurrent anticancer chemotherapy Endocrine therapy: * No concurrent steroids (including corticosteroids) Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * See Disease Characteristics * At least 3 weeks since prior major surgery Other: * At least 30 days since prior immune-based therapy * No concurrent participation in other clinical trials with investigational drugs * No other concurrent anticancer drugs * No concurrent immunosuppressive therapy * No concurrent levamisole or cimetidine

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

Sponsors & Collaborators

Study Sites (3)

Saint Francis Memorial Hospital

San Francisco, California, 94109, United States

Location

John Wayne Cancer Institute at Saint John's Health Center

Santa Monica, California, 90404, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Aurora, Colorado, 80010, United States

Location

Related Publications (1)

  • Weber RW, O'Day S, Rose M, Deck R, Ames P, Good J, Meyer J, Allen R, Trautvetter S, Timmerman M, Cruickshank S, Cook M, Gonzalez R, Spitler LE. Low-dose outpatient chemobiotherapy with temozolomide, granulocyte-macrophage colony stimulating factor, interferon-alpha2b, and recombinant interleukin-2 for the treatment of metastatic melanoma. J Clin Oncol. 2005 Dec 10;23(35):8992-9000. doi: 10.1200/JCO.2005.02.5791. Epub 2005 Oct 31.

    PMID: 16260693RESULT

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukinInterferon-alphasargramostimTemozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsDacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Lynn E. Spitler, MD

    Northern California Melanoma Center at St. Francis Memorial Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 10, 2001

First Posted

January 27, 2003

Study Start

December 1, 1999

Study Completion

December 1, 2003

Last Updated

March 26, 2013

Record last verified: 2004-03

Locations

US(3)