Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Anti-Infective Agents

Vaccines

Cyclophosphamide

Poly ICLC

Monatide (IMS 3015)

Freund's Adjuvant

Immunologic Factors

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Adjuvants, Immunologic

Interferons

Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.

Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:

* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)

Part 1: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.

Parts 1 and 2: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:

* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)

6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides

6MHP

Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant

Montanide ISA-51

polyICLC

Craig L. Slingluff, Jr., MD

This study evaluates whether it is safe to administer a peptide vaccine in combination with different adjuvants. Adjuvants are substances that may boost immune responses vaccines. In this study, the adjuvants are Montanide ISA-51, polyICLC and cyclophosphamide. This study will also evaluate the effects of the combination of the peptide vaccine and the adjuvants on the immune system. The investigators will monitor these effects by performing tests in the laboratory on participants' blood, a lymph node, and tissue from the sites of vaccination.

Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma

A Trial to Evaluate the Immunogenicity and Safety of a Melanoma Helper Peptide Vaccine Plus Novel Adjuvant Combinations (MEL63)

Treatment-related adverse events, by CTCAE v4, Dose-limiting toxicities.

CD4+ T cell responses to 6 MHP: durable helper T cell response to 6MHP at 2 or more consecutive timepoints in the PBMC.

increased infiltration of CD4+ and CD8+ T lymphocytes into melanoma metastases

CD8+ T cell responses to defined melanoma antigens

Ludwig Institute for Cancer Research

Cancer Research Institute, New York City

Craig L Slingluff, Jr

Director, Human Immune Therapy Center

The study will be monitored continuously for treatment-related adverse events.

A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria:

* ≥ Grade 3
* ≥ Grade 1 ocular adverse events as defined below
* ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.

Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.

6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides

Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant

Arm A:6MHP + Montanide ISA-51

Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:

* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)

  6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides

Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant

Cyclophosphamide: Cyclophosphamide, systemic adjuvant

Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide

Part 1: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78.

6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides

Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant

polyICLC: polyICLC, local adjuvant

Arm C:6MHP + polyICLC + Montanide ISA-51

Parts 1 and 2: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:

* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)

  6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides

Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant

polyICLC: polyICLC, local adjuvant

Cyclophosphamide: Cyclophosphamide, systemic adjuvant

Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Each participant was staged according to AJCC version 7 criteria at the time of study enrollment. Risk of death is generally higher for stage III than stage II, and within each stage, risk is higher for stage C than B than A. For those enrolled within 6 months of definitive therapy of the original diagnosis, the stage at diagnoses is used. For those enrolled after a subsequent recurrence or metastasis, the stage at recurrence was used.

Spots Global Cancer Trial Database for Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial