Vaccine Therapy in Treating Patients With Stage IV or Recurrent Melanoma

NCT00012064 | Completed Phase 1

• 3 other identifiers: CDR0000068481HOAG-VACCINE-MELNCI-V01-1646
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV or recurrent melanoma.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (2)

• To determine the safety of administration of irradiated autologous tumor cells that have been incubated in vitro with gamma interferon, and subsequently injected subcutaneously with autologous dendritic cells and GMCSF

  treatment

• To determine the frequency of conversion of delayed tumor hypersensitivity (DTH) tests with irradiated autologous tumor cells, in patients who received an autologous dendritic cell/tumor cell vaccine with GMCSF

  treatment

Secondary Outcomes (1)

• To determine the objective tumor response rate in patients with metastatic melanoma who still had measurable disease at the time vaccine treatment was given

  follow-up

Study Arms (1)

Biological/Vaccine

EXPERIMENTAL

Biological/Vaccine: therapeutic autologous dendritic cells. Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product.

Biological: therapeutic autologous dendritic cells

Interventions

therapeutic autologous dendritic cells BIOLOGICAL

Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product.

Biological/Vaccine

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed stage IV or recurrent melanoma * Metastatic disease confirmed by MRI or CT scan * Planned resection of tumor * No active CNS metastases * Radiographically confirmed lack of CNS disease progression * No requirement for pharmacologic doses of corticosteroids PATIENT CHARACTERISTICS: Age: * Over 16 Performance status: * ECOG 0-2 Life expectancy: * At least 4 months Hematopoietic: * Hematocrit greater than 25% * Platelet count greater than 100,000/mm\^3 * No ongoing transfusion requirements * No active blood clotting or bleeding diathesis Hepatic: * Bilirubin no greater than 2.0 mg/dL * Albumin at least 3.0 g/dL Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No underlying cardiac disease associated with known myocardial dysfunction * No unstable angina related to atherosclerotic cardiovascular disease Other: * No other malignancy within the past 5 years except for carcinoma in situ, basal cell carcinoma, or localized squamous cell skin cancer * No active, eminently life-threatening infection or medical condition * Adequate venous access * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Other prior putative vaccines allowed * Recovered from prior biologic therapy * No other concurrent biologic therapy except epoetin alfa for patients with hematocrit less than 36% Chemotherapy: * At least 3 weeks since prior chemotherapy and recovered * No concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * No concurrent endocrine therapy Radiotherapy: * At least 3 weeks since prior radiotherapy (including whole brain radiotherapy) and recovered * No concurrent radiotherapy Surgery: * See Disease Characteristics * Recovered from prior surgery Other: * Concurrent bisphosphonates allowed for patients with lytic bone metastases * No concurrent digoxin or other medications designed to improve cardiac output * No other concurrent investigational therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Lisata Therapeutics, Inc.: lead

Study Sites (1)

Hoag Cancer Center at Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Related Publications (1)

• Dillman RO, Schiltz PM, Selvan R, et al.: Patient-specific cancer vaccine of cultured autologous tumor cells and autologous dendritic cells. [Abstract] J Immunother 24 (5): S5, 2001.

  RESULT

MeSH Terms

Conditions

Melanoma

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

Study Officials

• Robert O. Dillman, MD, FACP

  Hoag Memorial Hospital Presbyterian

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 3, 2001
• First Posted: January 27, 2003
• Study Start: July 1, 2000
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: January 29, 2014

Record last verified: 2013-08

Locations

US (1)