Trial record 5 of 1353 for:
melanoma
Safety Study of a Melanoma Vaccine (GVAX) With or Without Cyclophosphamide in Patients With Surgically Resected Melanoma
This study is currently recruiting participants.
Verified November 2012 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Sidney Kimmel Comprehensive Cancer Center
Collaborator:
The John P. Hussman Foundation
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01435499
First received: September 8, 2011
Last updated: November 15, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma |
Biological: melanoma GVAX Drug: Cyclophosphamide |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:
Primary Outcome Measures:
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Administering Melanoma GVAX With and Without Cyclophosphamide [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]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 [ Time Frame: 2.5 Years ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 19 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort A
Cohort A will receive four doses of vaccine, each containing 5E7 melanoma GVAX cells.
|
Biological: melanoma GVAX
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.
|
|
Experimental: Cohort B
Cohort B will receive four doses of vaccine, each containing 2E8 melanoma GVAX cells.
|
Biological: melanoma GVAX
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.
|
|
Experimental: Cohort C
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.
|
Biological: melanoma GVAX
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.
Drug: Cyclophosphamide
200mg/m2 given as a single dose, intravenously, one day prior to each of the 4 vaccinations to patients in cohort C only
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435499
Locations
| United States, Maryland | |
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
| Baltimore, Maryland, United States, 21231 | |
| Contact: Susan Sartorius, RN 410-614-3644 | |
| Principal Investigator: Evan J Lipson, M.D. | |
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
The John P. Hussman Foundation
Investigators
| Principal Investigator: | Evan J Lipson, M.D. | The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
More Information
No publications provided
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01435499 History of Changes |
| Other Study ID Numbers: | J1112 |
| Study First Received: | September 8, 2011 |
| Last Updated: | November 15, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
|
immunotherapy vaccine GVAX GM-CSF |
Additional relevant MeSH terms:
|
Melanoma Nevi and Melanomas Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Cyclophosphamide Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |
ClinicalTrials.gov processed this record on May 22, 2013