Vaccine Therapy in Treating Patients With Stage IV Melanoma

NCT00033228 | Completed Phase 1

• 2 other identifiers: CDR0000069252CTL-26-35
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 5

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Infusing the vaccine directly into a lymph node may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (1)

• The primary objective of the study was to evaluate the safety and tolerability of Synchrovax® pSEM Vaccine measured by the adverse event and severe adverse event profile.

Secondary Outcomes (1)

• The secondary objective of the study was to determine the immunological response of patients as measured by tetramer assay and to assess clinical response by LDH levels and radiological assessment of lesions.

Study Arms (3)

Cohort 1

EXPERIMENTAL

The first cohort of 6 patients received 500 ug of Synchrovax SEM plasmid DNA vaccine. All patients were to be monitored for dose limiting toxicities DLTs) for a minimum of 2 weeks after their second infusion of vaccine on Day 15 before allowing patients to enroll at the next dose group. The decision to progress to the next dose group was to be based on occurrence of DLTs observed in 1 or fewer (\<33%) patients of a 6 patient cohort.

Biological: MKC1106-MT

Cohort 2

EXPERIMENTAL

The second cohort of 6 patients received 1000 ug of Synchrovax SEM plasmid DNA vaccine. All patients were to be monitored for dose limiting toxicities DLTs) for a minimum of 2 weeks after their second infusion of vaccine on Day 15 before allowing patients to enroll at the next dose group. The decision to progress to the next dose group was to be based on occurrence of DLTs observed in 1 or fewer (\<33%) patients of a 6 patient cohort.

Biological: MKC1106-MT

Cohort 3

EXPERIMENTAL

The third cohort of 6 patients received 1500 ug of Synchrovax SEM plasmid DNA vaccine. The maximum tolerated dose (MTD) was to be determined by the observation of DLT at each dose group.

Biological: MKC1106-MT

Interventions

MKC1106-MT BIOLOGICAL

Cancer Vaccine, Immunotherapy, 500 ug

Cohort 1

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed stage IV melanoma * Must have tumor tissue available for determining antigen expression * At least 10% of tumor cells must stain positive for Melan-A/Mart-1 by immunohistochemistry * HLA-A2 positive * No brain metastases unless completely resected or without evidence of disease after treatment PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * More than 3 months Hematopoietic: * Absolute neutrophil count at least 1,500/mm3 * WBC at least 3,000/mm3 * Platelet count at least 75,000/mm3 * Hemoglobin at least 9 g/dL Hepatic: * SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN * Bilirubin no greater than 1.5 times ULN * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal: * Creatinine no greater than 1.5 times ULN * Urea no greater than 2.6 times ULN Other: * Not pregnant, nursing, or planning to become pregnant within 6 months of treatment completion * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No medical, sociological, or psychological impediments that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy * At least 4 weeks since prior immunomodulatory drugs * No other concurrent immunotherapy * No concurrent immunomodulatory drugs Chemotherapy: * At least 4 weeks since prior chemotherapy * No concurrent chemotherapy Endocrine therapy: * At least 4 weeks since prior systemic corticosteroids * No concurrent systemic corticosteroids Radiotherapy: * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * At least 4 weeks since prior investigational drugs * No other concurrent investigational drugs

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

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (5)

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089, United States

Location

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Earle A. Chiles Research Institute at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

MeSH Terms

Conditions

Melanoma

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

Study Officials

• Chief Scientific Officer

  Mannkind Corporation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 9, 2002
• First Posted: January 27, 2003
• Study Start: January 1, 2002
• Primary Completion: March 1, 2003
• Study Completion: April 1, 2003
• Last Updated: May 12, 2011

Record last verified: 2011-05

Locations

US (5)