Comparison Study of Dendritic Cell Vaccine With and Without Cyclophosphamide to Treat Stage IV Melanoma Patients

NCT00722098 | Terminated Phase 2 DMC

• 1 other identifier: Baylor IRB #006-123
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the combination of chemotherapy (Cyclophosphamide) and CD34-DC vaccines results in the improved rate of clinical responses for stage IV melanoma patients.

Conditions

Malignant Melanoma Stage IV

Keywords

Melanoma; Dendritic Cell; Vaccine; Immunotherapy; Cyclophosphamide

Outcome Measures

Primary Outcomes (1)

• Induction of melanoma-specific CD8+T Cell Immunity.

  2 years

Secondary Outcomes (1)

• Rate of objective clinical responses.

  2 years

Study Arms (2)

DC Vaccine & Cyclophosphamide

EXPERIMENTAL

Patients will receive a fixed dose of about ≥15x106 viable dendritic cells per injection. Patients will receive a total of 8 doses of the vaccination with each individual dose being administered at weeks: 0, 2, 4, 6, 10, 14, 18 and 22. Responses will be evaluated and patients with SD, PR or CR may receive 4 more vaccine at 36, 48, 72 and 96 weeks, if there is vaccine available. The vaccine will be injected subcutaneously, in 3 separate injection sites (3.3.ml per site) in the upper and lower extremities. Patients will receive either CPA 300mg/m2 for injections administered intravenously over a 2-hour infusion in the outpatient clinic 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7.

Biological: DC Vaccine & Cyclophosphamide

DC Vaccine & Placebo

PLACEBO COMPARATOR

Patients will receive a fixed dose of about ≥15x106 viable dendritic cells per injection. Patients will receive a total of 8 doses of the vaccination with each individual dose being administered at weeks: 0, 2, 4, 6, 10, 14, 18 and 22. Responses will be evaluated and patients with SD, PR or CR may receive 4 more vaccine at 36, 48, 72 and 96 weeks, if there is vaccine available. The vaccine will be injected subcutaneously, in 3 separate injection sites (3.3.ml per site) in the upper and lower extremities. Patients will receive saline for injections administered intravenously over a 2-hour infusion in the outpatient clinic 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7.

Biological: DC Vaccine & Placebo

Interventions

DC Vaccine & Cyclophosphamide BIOLOGICAL

Patients will receive a fixed dose of about ≥15x106 viable dendritic cells per injection. Patients will receive a total of 8 doses of the vaccination with each individual dose being administered at weeks: 0, 2, 4, 6, 10, 14, 18 and 22. Responses will be evaluated and patients with SD, PR or CR may receive 4 more vaccine at 36, 48, 72 and 96 weeks, if there is vaccine available. The vaccine will be injected subcutaneously, in 3 separate injection sites (3.3.ml per site) in the upper and lower extremities. Patients will receive either CPA 300mg/m2 for injections administered intravenously over a 2-hour infusion in the outpatient clinic 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7.

Also known as: Cyclophosphamide (CPA), DC Vaccine ( Dendritic cell vaccine)

DC Vaccine & Cyclophosphamide

DC Vaccine & Placebo BIOLOGICAL

Patients will receive a fixed dose of about ≥15x106 viable dendritic cells per injection. Patients will receive a total of 8 doses of the vaccination with each individual dose being administered at weeks: 0, 2, 4, 6, 10, 14, 18 and 22. Responses will be evaluated and patients with SD, PR or CR may receive 4 more vaccine at 36, 48, 72 and 96 weeks, if there is vaccine available. The vaccine will be injected subcutaneously, in 3 separate injection sites (3.3.ml per site) in the upper and lower extremities. Patients will receive saline for injections administered intravenously over a 2-hour infusion in the outpatient clinic 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7.

Also known as: DC Vaccine - Dendritic Cell Vaccine

DC Vaccine & Placebo

Eligibility Criteria

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

You may qualify if:

• Biopsy-proven metastatic melanoma, Stages M1a, M1b, M1c
• HLA-A\*0201 phenotype
• Age: 21-75 years
• ECOG performance status 0-1
• Measurable metastatic melanoma lesions by physical examination or radiographs or scans.
• Adequate marrow function:
• White count ≥ 4,000/microliter: Subjects who have recently completed chemotherapy will be allowed study entry with White count ≥ 3,500/microliter
• Hemoglobin ≥ 10.0 gm: Subjects who have recently completed chemotherapy will be allowed study entry with Hemoglobin ≥ 9.0 gm.
• Platelets ≥ 100,000/microliter
• Adequate hepatic function:
• Bilirubin ≤ 1.5/mg/dL
• Alkaline phosphatase ≤ 5 times the upper limit of normal
• SGOT ≤ 5 times the upper limit of normal
• SGPT ≤ 5 times the upper limit of normal
• Adequate renal function:

You may not qualify if:

• Patients who have received \> 8 cycles of cytotoxic chemotherapy or metastatic melanoma
• Patients who have received any chemotherapy \< 4 weeks before the beginning of the trial
• Patients who have received interferon alpha (IFNα-2b) or sargramostim (GM-CSF) \< 4 weeks before the beginning of the trial
• Patients who have received high-dose interleukin-2 (IL-2) \< 4 weeks before the beginning of the trial
• Patients that have been diagnosed with more than 3 CNS melanoma lesions.
• Patients that have been diagnosed with more than 5 hepatic metastases or any hepatic metastasis \> 5 cm.
• Baseline serum LDH \> 1.1 times the upper limit of normal
• Patients who are HIV+ (HIV patients are often profoundly immunodeficient because of the viral infection and this additional parameter will interfere with the evaluation of DC induced immune responses in melanoma patients. Furthermore, the safety of collecting DCs, loading them with antigen and re-infusing these cells to HIV+ patients has not yet been determined.)
• Pregnancy (Pregnancy is associated with considerable immunosuppression 70 and this additional parameter will interfere with the evaluation of DC induced immune responses in melanoma patients. In addition, the safety and tolerability of cell body-loaded DC given subcutaneously is entirely unknown.)
• Patients who have received corticosteroids or other immunosuppressive agents \< 4 weeks before beginning the trial
• Patients with active asthma and/or on treatment for asthma
• Patients with angina pectoris
• Patients with congestive heart failure
• Patients with a history of autoimmune disease including lupus erythematosus, rheumatoid arthritis or thyroiditis
• Patients with active infections including viral hepatitis

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75204, 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 Fay, M.D.

  Baylor Institute for Immunology Research: Baylor University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2008
• First Posted: July 25, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: July 1, 2012
• Last Updated: July 8, 2013

Record last verified: 2013-07

Locations

US (1)