Combined Modality Treatment for Patients With Stage IV Melanoma

NCT00313235 | Completed Phase 1 DMC

• 2 other identifiers: Baylor IRB #006-025-01IND 12919
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test a combined treatment using cyclophosphamide and a novel dendritic cell vaccine in patients with Stage IV melanoma.

Conditions

Malignant Melanoma Stage IV

Keywords

Dendritic Vaccine; Melanoma; Cyclophosphamide (CPA)

Outcome Measures

Primary Outcomes (3)

• Safety and tolerability of the combination of DC vaccination and CPA therapy in human subjects

  2 Years

• Feasibility of this combination therapy

  2 Years

• Objective clinical responses

  2 Years

Secondary Outcomes (2)

• Immunogenicity of DC vaccinations in subjects

  2 Years

• Effect of CPA at this dose and schedule on the regulatory/suppressor T cells

  2 years

Study Arms (1)

DC Vaccine and Cyclophosphamide

EXPERIMENTAL

Autologous dendritic cells (DC) are derived from PBMC, cultured with cytokines, pulsed ex vivo with irradiated allogeneic (Colo 829) melanoma cells. About 15 x 10\^6 dendritic cells will be injected subcutaneously, in 3 separate sites (3.3 ml/site). Patients will receive a total of 7 doses of the vaccination. Each individual dose will be administered at weeks: 0, 2, 4, 6, 11, 14, and 18. Patients with SD, PR according to RECIST criteria may receive 4 more vaccines at 36, 48, 60 and 72 weeks. Patients with CR will receive 4 additional vaccines at 36, 48, 72, and 96 weeks. CPA will be administered 300mg/m2, intravenously over a 2-hour infusion 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7. Frequency of CPA administration might be increased based on their T cell measure.

Biological: DC Vaccine and Cyclophosphamide

Interventions

DC Vaccine and Cyclophosphamide BIOLOGICAL

Autologous dendritic cells (DC) are derived from PBMC, cultured with cytokines, pulsed ex vivo with irradiated allogeneic (Colo 829) melanoma cells. About 15 x 10\^6 dendritic cells will be injected subcutaneously, in 3 separate sites (3.3 ml/site). Patients will receive a total of 7 doses of the vaccination. Each individual dose will be administered at weeks: 0, 2, 4, 6, 11, 14, and 18. Patients with SD, PR according to RECIST criteria may receive 4 more vaccines at 36, 48, 60 and 72 weeks. Patients with CR will receive 4 additional vaccines at 36, 48, 72, and 96 weeks. CPA will be administered 300mg/m2, intravenously over a 2-hour infusion 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7. Frequency of CPA administration might be increased based on their T cell measure.

Also known as: Cyclophosphamide - CPA, Dendritic Cell Vaccine - DC Vaccine

DC Vaccine and Cyclophosphamide

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage M1a, M1b, M1c biopsy proven metastatic melanoma.
• Ages 21-75.
• Karnofsky performance status greater than/equal to 80%.
• Measurable metastatic lesions by physical exam or scans.
• Acceptable CBC and blood chemistry results.
• Adequate hepatic and renal function.
• No active CNS metastatic disease. If CNS history is present, lesions must have been resected by surgery and/or gamma knife irradiation at least 3 months prior to study entry. The total number of CNS lesions at diagnosis should not exceed 3.
• Written informed consent.

You may not qualify if:

• Patients that have received more than 8 cycles of chemotherapy for metastatic melanoma.
• Patients who have received chemotherapy less than 4 weeks before beginning the trial.
• Patients who have received IFN alpha-2b or GM-CSF less than 4 weeks before beginning the trial.
• Patients who have received high-dose IL-2 less than 4 weeks before beginning the trial.
• Patients diagnosed with more than 3 CNS metastatic melanoma lesions.
• More than 5 hepatic lesions or any hepatic lesion larger than 5 cm.
• Baseline serum LDH greater than 1.1 times the upper limit of normal.
• Patients who are HIV positive.
• Patients who are pregnant.
• Patients who have receive corticosteroids or other agents less than 4 weeks before beginning the trial.
• Patients with asthma, angina pectoris or congestive heart failure.
• Patients with autoimmune disease such as lupus erythematosus, rheumatoid arthritis or thyroiditis.
• Patients with active infections including viral hepatitis.
• Patients with a history of any other neoplastic disease less than 5 years ago (carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin, however, can be admitted to the study).

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Joseph W. Fay, MD

  Baylor Health Care System

  PRINCIPAL INVESTIGATOR

• Anna Karolina Palucka, MD, PhD

  Baylor Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2006
• First Posted: April 12, 2006
• Study Start: March 1, 2006
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2012
• Last Updated: June 13, 2013

Record last verified: 2013-06

Locations

US (1)