search
Back to results

Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
recombinant interferon alfa
sargramostim
temozolomide
Sponsored by
Saint Francis Memorial Hospital
About
Eligibility
Locations
Outcomes
Full info

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 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

Sites / Locations

  • Saint Francis Memorial Hospital
  • John Wayne Cancer Institute at Saint John's Health Center
  • University of Colorado Cancer Center at University of Colorado Health Sciences Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 10, 2001
Last Updated
March 25, 2013
Sponsor
Saint Francis Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00014092
Brief Title
Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery
Official Title
Treatment of Patients With Metastatic Malignant Melanoma With Chemobiotherapy With Temozolomide, GM-CSF, IL2, and Interferon Alfa-2b Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2004
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Saint Francis Memorial Hospital

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. 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.
Detailed Description
OBJECTIVES: Determine the response rate, time to progression, and survival of patients with unresectable stage IV melanoma treated with temozolomide followed by sargramostim (GM-CSF), interleukin-2, and interferon alfa. Determine the safety and tolerability of this regimen in this patient population. Determine the changes in quality of life over time in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral temozolomide on days 1-5, and sargramostim (GM-CSF), interleukin-2, and interferon alfa subcutaneously on days 6-17. Treatment repeats every 28 days for 4-8 courses in the absence of disease progression or unacceptable toxicity. Patients with at least stable or responsive disease after 8 courses of therapy may receive additional therapy at investigators discretion. Quality of life is assessed at baseline, every 8 weeks during study, and then at 1 month after study. Patients are followed at 1 month, every 3 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 2 years.

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

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Drug
Intervention Name(s)
temozolomide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn E. Spitler, MD
Organizational Affiliation
Northern California Melanoma Center at St. Francis Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Saint Francis Memorial Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
John Wayne Cancer Institute at Saint John's Health Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of Colorado Cancer Center at University of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16260693
Citation
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.
Results Reference
result

Learn more about this trial

Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery

We'll reach out to this number within 24 hrs