Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 514 for:    melanoma phase III

Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00003647
Recruitment Status : Completed
First Posted : March 23, 2004
Last Update Posted : July 25, 2008
Sponsor:
Information provided by:
Vical

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE March 23, 2004
Last Update Posted Date July 25, 2008
Study Start Date  ICMJE July 1998
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00003647 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma
Official Title  ICMJE Phase III Randomized Study of Dacarbazine With or Without Allovectin-7 in Patients With Metastatic Melanoma
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of dacarbazine with or without immunotherapy in treating patients who have stage III or stage IV melanoma.

Detailed Description

OBJECTIVES: I. Demonstrate either an improvement in the median time to disease progression by at least 2 months with no decrease in the rate of objective clinical response OR an improvement by at least 15% in the rate of objective clinical response with no decrease in the median time to disease progression in patients with stage III or IV melanoma receiving dacarbazine with Allovectin-7 when compared with patients receiving dacarbazine alone.

II. Determine the benefits, risks, and side effects of these regimens in this patient population.

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to sex, age, and spread of disease (cutaneous or nodal vs visceral disease). Patients are randomized to one of two treatment arms.

Arm I: Patients receive dacarbazine IV over 1 hour on day 0. Arm II: Patients receive treatment as in arm I. Patients also receive Allovectin-7 intratumorally on days 3 and 10.

Patients with stable or responding disease may receive additional courses every 28 days.

Patients are followed every 4 months.

PROJECTED ACCRUAL:

A total of 280 patients (140 in each arm) will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Stage IV Melanoma
  • Stage III Melanoma
  • Recurrent Melanoma
Intervention  ICMJE
  • Drug: allovectin-7
  • Drug: allovectin-7/dacarbazine
  • Drug: dacarbazine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Histologically confirmed stage III or IV melanoma 1 or more metastatic tumors for which surgery is not deemed to be a curative option
  • Dacarbazine is indicated as first line chemotherapy
  • At least 1 measurable tumor at least 1 cm2 but no greater than 100 cm2
  • No history of brain metastases

--Prior/Concurrent Therapy--

  • Biologic therapy: At least 4 weeks since prior biologic therapy
  • Chemotherapy: See Disease Characteristics; No prior chemotherapy
  • Endocrine therapy: No concurrent immunosuppressive drugs
  • Radiotherapy: At least 4 weeks since prior radiotherapy
  • Surgery: At least 2 weeks since prior major surgery
  • Other: No other concurrent anticancer drug therapy or experimental therapy

--Patient Characteristics--

  • Age: 18 and over
  • Performance status: Karnofsky 80-100%
  • Life expectancy: At least 24 weeks
  • Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL
  • Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT/SGPT less than 3 times upper limit of normal (ULN); PT/PTT normal; Albumin normal; LDH no greater than 2 times ULN
  • Renal: Creatinine no greater than 2.0 mg/dL
  • Cardiovascular: No uncontrolled hypertension; No New York Heart Association class III or IV disease
  • Other: HIV negative; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No active autoimmune disease; No active infection requiring parenteral antibiotics; No uncontrolled diabetes mellitus; No other prior malignancy within the past 5 years except skin cancer or stage 0-II cervical cancer; No significant psychiatric disorders
Sex/Gender  ICMJE Not Provided
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003647
Other Study ID Numbers  ICMJE CDR0000066736
VCL-1005-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Vical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Cherie Smith Vical
PRS Account Vical
Verification Date July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP