Vaccine Therapy in Treating Patients With Stage IV Melanoma

NCT ID: NCT00023647

Last Updated: 2012-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-07-31
• Study Completion Date: 2002-11-30

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 trial to study the effectiveness of vaccine therapy given directly into a lymph node in treating patients who have stage IV melanoma.

Detailed Description

OBJECTIVES: I. Determine the safety and tolerability of intranodal Synchrotope TA2M plasmid DNA vaccine in patients with stage IV melanoma. II. Determine the immune response of patients treated with this vaccine. III. Determine the clinical response of patients treated with this vaccine.

OUTLINE: This is dose-escalation, multicenter study. Patients receive Synchrotope TA2M plasmid DNA vaccine intranodally continuously over 96 hours beginning on days 0, 14, 28, and 42. Treatment continues for up to 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 8 patients receive escalating doses of Synchrotope TA2M plasmid DNA vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 8 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 16-24 patients will be accrued for this study within 12 months.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Synchrotope TA2M, 800 micrograms

Tyrosinase peptides, 800 micrograms

Group Type: EXPERIMENTAL

Synchrotope TA2M

Intervention Type: BIOLOGICAL

Cancer Vaccine, Immunotherapy

Synchrotope TA2M, 200 micrograms

Tyrosinase peptides, 200 micrograms

Group Type: EXPERIMENTAL

Synchrotope TA2M

Intervention Type: BIOLOGICAL

Cancer Vaccine, Immunotherapy

Synchrotope TA2M, 400 micrograms

Tyrosinase peptides, 400 micrograms

Group Type: EXPERIMENTAL

Synchrotope TA2M

Intervention Type: BIOLOGICAL

Cancer Vaccine, Immunotherapy

Interventions

Synchrotope TA2M

Cancer Vaccine, Immunotherapy

Intervention Type: BIOLOGICAL

Synchrotope TA2M

Cancer Vaccine, Immunotherapy

Intervention Type: BIOLOGICAL

Synchrotope TA2M

Cancer Vaccine, Immunotherapy

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. The patients or their legally acceptable representative must give signed informed consent for participation in the study before any study procedure is performed.

2. Patients must be 18 years of age or older at pre-study

3. Patients must be ambulatory, ECOG performance status of 0 or 1 (Appendix II)

4. Patients have histologically confirmed diagnosis of Stage IV melanoma according to AJCC/UICC modified system with an expected survival time of more than 3 months

5. Patients must be positive for HLA-A2 (Patients tested positive within 5 years of pre-study screening do not need to be tested again for HLA-A2)

6. Patients must agree to use an acceptable method of birth control

1. intrauterine device

2. oral hormonal contraception

3. combination of spermicide and barrier method or

4. abstinence

7. Female patients of childbearing potential must have a confirmed negative urine pregnancy test on Day 0

Exclusion Criteria

1. Patients who have hematological abnormalities as evidenced by:

1. Neutrophils < 1,500/mm3

2. Leukocytes < 3,000/mm3

3. Platelets < 75,000/mm3

4. Hemoglobin < 9.0 g/dL

2. Patients who have hepatic disease as evidenced by:

1. SGOT/SGPT (AST/ALT) > 2.5 x the upper limit of normal (ULN)

2. alkaline phosphatase > 2.5 x ULN

3. Bilirubin > 1.5 x ULN\

4. positive for hepatitis B surface antigen

5. positive for hepatitis C antibody

3. Patients who have known or suspected renal impairment as evidenced by:

1. serum creatinine > 1.5 x ULN, and/or

2. serum urea > 2.6 x ULN

4. Patients with a history of ocular melanoma

5. Patients with brain metastases, unless completed resected

6. Patients with a positive HIV antibody test

7. Patients with medical, sociological, or psychological impediments that may compromise compliance with the protocol

8. Patients who are nursing, pregnant or planning to become pregnant within 6 months of treatment completion

9. Patients who are receiving chemo-, radio- or immunotherapy concurrently or within the preceding four weeks

10. Patients who are taking drugs that affect immune function such as systemic corticosteroids or immunomodulatory drugs concurrently or within the preceding four weeks

11. Patients who are receiving any investigational drug concurrently or within the preceding four weeks

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mannkind Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Hickingbottom, JD, MD

Role: STUDY_CHAIR

Mannkind Corporation

Locations

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Countries

United States

References

Tagawa ST, Lee P, Snively J, Boswell W, Ounpraseuth S, Lee S, Hickingbottom B, Smith J, Johnson D, Weber JS. Phase I study of intranodal delivery of a plasmid DNA vaccine for patients with Stage IV melanoma. Cancer. 2003 Jul 1;98(1):144-54. doi: 10.1002/cncr.11462.

Reference Type: RESULT

PMID: 12833467 (View on PubMed)

Other Identifiers

CTL-207-216

Identifier Type: -

Identifier Source: secondary_id

CTL-BB-IND-9146

Identifier Type: -

Identifier Source: secondary_id

LAC-USC-10M001

Identifier Type: -

Identifier Source: secondary_id

NCI-V01-1666

Identifier Type: -

Identifier Source: secondary_id

CDR0000068847

Identifier Type: -

Identifier Source: org_study_id