Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00003339
Other study ID # CDR0000066310 (10M-97-3)
Secondary ID LAC-USC-10M973NC
Status Completed
Phase Phase 2
First received November 1, 1999
Last updated May 20, 2014
Start date November 1998
Est. completion date September 2004

Study information

Verified date May 2014
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response that will kill tumor cells. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating white blood cells to kill melanoma cells.

PURPOSE: Randomized phase II trial to determine the effectiveness of vaccine therapy given with interleukin-12 in treating patients who have stage III or stage IV melanoma.


Description:

OBJECTIVES: I. Evaluate immune reactivity to tyrosinase and gp100 peptides emulsified with Montanide ISA-51 (ISA-51) with or without interleukin-12 following surgical resection in HLA-A2 positive patients with stage III or IV melanoma.

OUTLINE: This is a randomized, parallel study. Patients are stratified by prior therapy (immunotherapy or chemotherapy vs surgery only). Patients are randomized to receive 1 of 2 treatment arms: Arm I: Following surgery, patients receive tyrosinase and gp100 peptides emulsified with Montanide ISA-51 (ISA-51) subcutaneously (SQ) once weekly during weeks 0, 2, 4, 6, 10, 14, 18, and 26 for a total of 8 vaccinations. Arm II: Following surgery, patients receive treatment as in Arm I followed by interleukin-12 SQ once weekly during weeks 0, 2, 4, 6, 10, 14, 18, and 26 for a total of 8 vaccinations. Patients are followed at 2-4 weeks, then every 3 months for 2 years after resection, then every 6 months for 3 years, and then yearly if without evidence of disease.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study over 2 years.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date September 2004
Est. primary completion date November 1999
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility DISEASE CHARACTERISTICS: Histologically proven stage III or IV cutaneous or ocular melanoma that can be completely resected or rendered free of disease but is at high risk of recurrence OR Recurrent disease following interferon alfa or ineligible for or refused interferon alfa HLA-A2 positive Tumor tissue must be available for analysis of gp100/tyrosinase expression Detectable expression of one or the other antigen not required

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No major cardiovascular illness Pulmonary: No major respiratory illness (e.g., pneumonia) Gastrointestinal: No major gastrointestinal illness Other: Not pregnant or nursing No major systemic infection (e.g., sepsis) No coagulation or bleeding disorder HIV negative Hepatitis B surface antigen negative Hepatitis C surface antigen negative No history of uveitis or autoimmune inflammatory eye disease No active autoimmune disease Not allergic to Montanide ISA-51 No active second malignancy within the past 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 1 month since prior biologic therapy Chemotherapy: At least 1 month since prior chemotherapy, including adjuvant therapy Endocrine therapy: At least 1 month since prior endocrine therapy No concurrent steroid therapy Radiotherapy: At least 1 month since prior radiotherapy Surgery: See Disease Characteristics At least 1 month since prior surgery

Study Design

Allocation: Randomized, Primary Purpose: Treatment


Intervention

Biological:
gp100 antigen

incomplete Freund's adjuvant

recombinant interleukin-12

tyrosinase peptide


Locations

Country Name City State
United States Beckman Research Institute, City of Hope Duarte California
United States USC/Norris Comprehensive Cancer Center Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
University of Southern California National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Completed NCT04062032 - Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Subjects at Risk for Melanoma Phase 2
Completed NCT03620019 - Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma Phase 2
Active, not recruiting NCT03291002 - Study of Intratumoral CV8102 in cMEL, cSCC, hnSCC, and ACC Phase 1
Completed NCT04534309 - Behavioral Weight Loss Program for Cancer Survivors in Maryland N/A
Completed NCT00962845 - Hydroxychloroquine in Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery Early Phase 1
Completed NCT00324623 - Cyclophosphamide and Fludarabine Followed by Cellular Adoptive Immunotherapy and Vaccine Therapy in Patients With Metastatic Melanoma Phase 1
Completed NCT00096382 - Cyclophosphamide, Fludarabine, and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy, Autologous Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Metastatic Melanoma Phase 2
Completed NCT00104845 - Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma Phase 1
Completed NCT00072085 - Immunization With gp100 Protein Vaccine in Treating Patients With Metastatic Melanoma Phase 2
Completed NCT00089193 - Vaccine Therapy With or Without Sargramostim in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma Phase 2
Completed NCT00072124 - Dacarbazine and/or Cisplatin Compared With Complete Metastasectomy in Treating Patients With Stage IV Melanoma Phase 3
Active, not recruiting NCT00039234 - Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver Phase 3
Completed NCT00049010 - Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma N/A
Completed NCT00042783 - Vaccine Therapy in Treating Patients With Stage IV Melanoma Phase 2
Completed NCT00006385 - Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma Phase 2
Completed NCT00006022 - Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer Phase 1
Completed NCT00020358 - Vaccine Therapy in Treating Patients With Melanoma Phase 2
Completed NCT00005610 - Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung Phase 2
Recruiting NCT03767348 - Study of RP1 Monotherapy and RP1 in Combination With Nivolumab Phase 2
Withdrawn NCT00006126 - Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery Phase 1