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Vaccine Therapy in Treating Patients With Stage IV Melanoma

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MKC1106-MT
MKC1106-MT
MKC1106-MT
Sponsored by
Mannkind Corporation
About
Eligibility
Locations
Arms
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 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

Sites / Locations

  • Arizona Cancer Center at University of Arizona Health Sciences Center
  • USC/Norris Comprehensive Cancer Center and Hospital
  • Cancer Research Center at Boston Medical Center
  • Mayo Clinic Cancer Center
  • Earle A. Chiles Research Institute at Providence Portland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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 Outcome Measures

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.

Full Information

First Posted
April 9, 2002
Last Updated
May 11, 2011
Sponsor
Mannkind Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00033228
Brief Title
Vaccine Therapy in Treating Patients With Stage IV Melanoma
Official Title
A Phase I/II Pilot Study Of Intranodal Delivery Of A Plasmid DNA (Synchrovax SEM Vaccine) In Stage IV Melanoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
April 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mannkind Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
OBJECTIVES: Determine the maximum tolerated dose of intranodal Synchrovax SEM plasmid DNA vaccine in patients with stage IV melanoma. Determine the safety and tolerability of this drug in these patients. Determine the immunological response, as measured by changes in frequency of T cells specific against vaccine-encoded epitopes before and after treatment, in patients treated with this drug. Determine the clinical response, as measured by lactic dehydrogenase levels and radiologic assessment of lesions, in patients treated with this drug. OUTLINE: This is a multicenter, dose-escalation study. Patients receive Synchrovax SEM plasmid DNA vaccine by continuous intranodal infusion on days 1-4. Treatment repeats every 14 days for up to 4 courses in the absence of unacceptable toxicity. Patients with evidence of stable or responding disease are eligible for 4 additional courses of treatment. Cohorts of 6 patients receive escalating doses of Synchrovax SEM plasmid DNA vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 10 days after the last dose of study drug. PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for this study.

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 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
MKC1106-MT
Intervention Description
Cancer Vaccine, Immunotherapy, 500 ug
Intervention Type
Biological
Intervention Name(s)
MKC1106-MT
Intervention Description
Cancer Vaccine, Immunotherapy, 1000 ug
Intervention Type
Biological
Intervention Name(s)
MKC1106-MT
Intervention Description
Cancer Vaccine, Immunotherapy, 1500 ug
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Scientific Officer
Organizational Affiliation
Mannkind Corporation
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona Cancer Center at University of Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Facility Name
Cancer Research Center at Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Earle A. Chiles Research Institute at Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213-2967
Country
United States

12. IPD Sharing Statement

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Vaccine Therapy in Treating Patients With Stage IV Melanoma

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