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Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
autologous tumor cell vaccine
therapeutic autologous dendritic cells
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage III melanoma, stage IV melanoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed melanoma Stage III (lymph node or in-transit metastases) or IV (systemic metastases) disease Patients with relapsed disease OR who failed prior immunotherapy or chemotherapy are eligible (but trial not restricted to relapsed or refractory disease) Tumor tissue available and properly stored for lysate preparation PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 75,000/mm^3 Hepatic AST ≤ 2 times upper limit of normal (ULN) (3 times ULN for liver metastases) Bilirubin ≤ 2 times ULN Hepatitis B surface antigen negative Hepatitis C negative Renal Creatinine ≤ 2.0 times ULN Immunologic No active infection No history of autoimmune disease, including any of the following: Inflammatory bowel disease Systemic lupus erythematosus Scleroderma Rheumatoid arthritis Multiple sclerosis No allergy to aminoglycosides or streptomycin HIV negative Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant comorbid illness No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics At least 10 days since prior immunotherapy Chemotherapy See Disease Characteristics Endocrine therapy At least 6 weeks since prior steroid therapy No concurrent corticosteroids Radiotherapy At least 10 days since prior radiotherapy No concurrent radiotherapy Surgery At least 10 days since prior surgery Prior diagnostic or palliative surgery allowed provided the patient has fully recovered Other No concurrent immunosuppressive or potentially immunosuppressive therapy

Sites / Locations

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Outcomes

Primary Outcome Measures

Ex Vivo Matured Dendritic Cell Therapy in Patients with Melanoma

Secondary Outcome Measures

Full Information

First Posted
June 10, 2004
Last Updated
January 30, 2015
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00085488
Brief Title
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Official Title
En Vivo Matured Dendritic Cell Therapy in Patients With Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Vaccines made from a patient's dendritic cells and tumor cells may make the body build an immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage III or stage IV melanoma.
Detailed Description
OBJECTIVES: Primary Determine the dose-limiting toxicity and the maximum tolerated dose of autologous dendritic cells pulsed with autologous tumor cell lysate in patients with stage III or IV melanoma. Determine the safety and tolerability of this therapy in these patients. Secondary Determine the immune response, in terms of the type and degree of T-cell proliferation and delayed-type hypersensitivity responses, in patients treated with this therapy. OUTLINE: This is a dose-escalation, pilot study. Patients undergo leukapheresis for the collection of peripheral blood mononuclear cells (PBMC) on days -9, 19, and 47. Autologous dendritic cells (DC) are prepared from autologous PBMC exposed to sargramostim (GM-CSF), interleukin-4, and tumor necrosis factor alpha and pulsed with autologous tumor cell lysate. Patients receive autologous tumor cell lysate-pulsed DC IV over 5-10 minutes on days 0, 28, and 56. Cohorts of 3-6 patients receive escalating doses of autologous tumor cell lysate-pulsed DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 33% of all patients experience dose-limiting toxicity. Patients are followed at day 84 and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 3-20 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
recurrent melanoma, stage III melanoma, stage IV melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
autologous tumor cell vaccine
Intervention Type
Biological
Intervention Name(s)
therapeutic autologous dendritic cells
Primary Outcome Measure Information:
Title
Ex Vivo Matured Dendritic Cell Therapy in Patients with Melanoma
Time Frame
2005-2006

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed melanoma Stage III (lymph node or in-transit metastases) or IV (systemic metastases) disease Patients with relapsed disease OR who failed prior immunotherapy or chemotherapy are eligible (but trial not restricted to relapsed or refractory disease) Tumor tissue available and properly stored for lysate preparation PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 75,000/mm^3 Hepatic AST ≤ 2 times upper limit of normal (ULN) (3 times ULN for liver metastases) Bilirubin ≤ 2 times ULN Hepatitis B surface antigen negative Hepatitis C negative Renal Creatinine ≤ 2.0 times ULN Immunologic No active infection No history of autoimmune disease, including any of the following: Inflammatory bowel disease Systemic lupus erythematosus Scleroderma Rheumatoid arthritis Multiple sclerosis No allergy to aminoglycosides or streptomycin HIV negative Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant comorbid illness No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics At least 10 days since prior immunotherapy Chemotherapy See Disease Characteristics Endocrine therapy At least 6 weeks since prior steroid therapy No concurrent corticosteroids Radiotherapy At least 10 days since prior radiotherapy No concurrent radiotherapy Surgery At least 10 days since prior surgery Prior diagnostic or palliative surgery allowed provided the patient has fully recovered Other No concurrent immunosuppressive or potentially immunosuppressive therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher P. Tretter, MD
Organizational Affiliation
Norris Cotton Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma

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