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Safety Study of a Melanoma Vaccine (GVAX) With or Without Cyclophosphamide in Patients With Surgically Resected Melanoma

Primary Purpose

Melanoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

melanoma GVAX

Cyclophosphamide

About this trial

This is an interventional treatment trial for Melanoma focused on measuring immunotherapy, vaccine, GVAX, GM-CSF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Any patient age ≥18 years with melanoma of cutaneous or mucosal origin, and with clinicopathologic stage IIB, IIC, III or IV that has been completely resected
Patients must be able to provide informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy of at least 6 months.
Adequate hematologic function.
Adequate renal function
Adequate hepatic function
Patients of both genders must agree to practice effective birth control during the study period and for at least 4 weeks after the last treatment.

Exclusion Criteria:

Patients whose primary site of melanoma is ocular.
Are undergoing or have undergone in the past 4 weeks any systemic treatment for melanoma.
Are undergoing or have undergone in the past 2 weeks any surgery or focal radiation therapy.
Have active systemic infections, coagulation disorders (including therapeutic anticoagulation), or other major medical or psychiatric illnesses.
Are known to be positive for hepatitis B surface antigen, anti-Hepatitis C Virus or anti-Human Immunodeficiency Virus (HIV) antibody (because of possible immune effects of these conditions).
Documented history of autoimmune disease, for example, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis.
Any form of primary or secondary immunodeficiency. This would include hereditary disorders such as ataxia-telangiectasia or Wiskott-Aldrich syndrome, or acquired immune deficiencies such as following bone marrow transplantation.
Requirement for systemic steroid therapy or immunosuppressive therapy.
Have received any type of cancer immunotherapy, including but not limited to interleukin-2, interferon alfa or melanoma vaccines.
Have been diagnosed with another invasive cancer within the past 3 years.
Radiographic evidence of melanoma recurrence.
Pregnant or lactating women.
Known or suspected hypersensitivity to GM-CSF, pentastarch, hetastarch, corn, Dimethyl sulfoxide, fetal bovine serum or trypsin (porcine origin).

Sites / Locations

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cohort A

Cohort B

Cohort C

Arm Description

Cohort A will receive four doses of vaccine, each containing 5E7 melanoma GVAX cells.

Cohort B will receive four doses of vaccine, each containing 2E8 melanoma GVAX cells.

Cohort C will receive four doses of vaccine, each containing 2E8 melanoma GVAX cells. One day prior to each vaccination, patients in cohort C will receive a single, low dose of intravenous cyclophosphamide.

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Administering Melanoma GVAX With and Without Cyclophosphamide

To determine the side effects and tolerability of administering an allogeneic GM-CSF-secreting lethally irradiated whole melanoma cell vaccine ("melanoma GVAX"), alone or in combination with low dose cyclophosphamide, for the adjuvant treatment of patients with surgically resected stage IIB-IV melanoma.

Secondary Outcome Measures

In vitro correlates of anti-melanoma immunization

We will assess in vitro correlates of anti-melanoma immunization by melanoma GVAX, including serological and cellular immune responses in patients treated with either the vaccine alone or the vaccine given with low dose cyclophosphamide. These investigations are exploratory in nature and will not affect clinical care.

Full Information

NCT ID

NCT01435499

First Posted

September 8, 2011

Last Updated

May 23, 2016

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

The John P. Hussman Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01435499

Brief Title

Safety Study of a Melanoma Vaccine (GVAX) With or Without Cyclophosphamide in Patients With Surgically Resected Melanoma

Official Title

A Feasibility and Toxicity Study of a Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Secreting Allogeneic Melanoma Vaccine Administered Alone or in Combination With Cyclophosphamide in Subjects With Surgically Resected At-Risk Melanoma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

The John P. Hussman Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective of this study is to evaluate the safety and feasibility of administering an allogeneic GM-CSF-secreting lethally irradiated whole melanoma cell vaccine ("melanoma GVAX"), alone or in combination with low dose cyclophosphamide (CPM), for the adjuvant treatment of patients with surgically resected stage IIB-IV melanoma. Secondarily, the investigators will assess in vitro correlates of anti-melanoma immunization by melanoma GVAX, including serological and cellular immune responses in patients treated with either the vaccine alone or the vaccine given with low dose CPM.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

Keywords

immunotherapy, vaccine, GVAX, GM-CSF

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort A

Arm Type

Experimental

Arm Description

Cohort A will receive four doses of vaccine, each containing 5E7 melanoma GVAX cells.

Arm Title

Cohort B

Arm Type

Experimental

Arm Description

Cohort B will receive four doses of vaccine, each containing 2E8 melanoma GVAX cells.

Arm Title

Cohort C

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

melanoma GVAX

Intervention Description

Melanoma GVAX is given as intradermal injections every 28 days x 4 doses. Cohort A will receive 5E7 cells/dose; cohorts B and C will receive 2E8 cells/dose.

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Description

200mg/m2 given as a single dose, intravenously, one day prior to each of the 4 vaccinations to patients in cohort C only

Primary Outcome Measure Information:

Title

Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Administering Melanoma GVAX With and Without Cyclophosphamide

Description

Time Frame

2.5 years

Secondary Outcome Measure Information:

Title

In vitro correlates of anti-melanoma immunization

Description

Time Frame

2.5 Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Any patient age ≥18 years with melanoma of cutaneous or mucosal origin, and with clinicopathologic stage IIB, IIC, III or IV that has been completely resected Patients must be able to provide informed consent. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Life expectancy of at least 6 months. Adequate hematologic function. Adequate renal function Adequate hepatic function Patients of both genders must agree to practice effective birth control during the study period and for at least 4 weeks after the last treatment. Exclusion Criteria: Patients whose primary site of melanoma is ocular. Are undergoing or have undergone in the past 4 weeks any systemic treatment for melanoma. Are undergoing or have undergone in the past 2 weeks any surgery or focal radiation therapy. Have active systemic infections, coagulation disorders (including therapeutic anticoagulation), or other major medical or psychiatric illnesses. Are known to be positive for hepatitis B surface antigen, anti-Hepatitis C Virus or anti-Human Immunodeficiency Virus (HIV) antibody (because of possible immune effects of these conditions). Documented history of autoimmune disease, for example, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis. Any form of primary or secondary immunodeficiency. This would include hereditary disorders such as ataxia-telangiectasia or Wiskott-Aldrich syndrome, or acquired immune deficiencies such as following bone marrow transplantation. Requirement for systemic steroid therapy or immunosuppressive therapy. Have received any type of cancer immunotherapy, including but not limited to interleukin-2, interferon alfa or melanoma vaccines. Have been diagnosed with another invasive cancer within the past 3 years. Radiographic evidence of melanoma recurrence. Pregnant or lactating women. Known or suspected hypersensitivity to GM-CSF, pentastarch, hetastarch, corn, Dimethyl sulfoxide, fetal bovine serum or trypsin (porcine origin).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Evan J Lipson, M.D.

Organizational Affiliation

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26143264

Citation

Lipson EJ, Sharfman WH, Chen S, McMiller TL, Pritchard TS, Salas JT, Sartorius-Mergenthaler S, Freed I, Ravi S, Wang H, Luber B, Sproul JD, Taube JM, Pardoll DM, Topalian SL. Safety and immunologic correlates of Melanoma GVAX, a GM-CSF secreting allogeneic melanoma cell vaccine administered in the adjuvant setting. J Transl Med. 2015 Jul 5;13:214. doi: 10.1186/s12967-015-0572-3.

Results Reference

derived

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Safety Study of a Melanoma Vaccine (GVAX) With or Without Cyclophosphamide in Patients With Surgically Resected Melanoma

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