Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer

NCT00017537 | Withdrawn Phase 1 DMC

• 3 other identifiers: CDR0000068700UAB-0020NCI-G01-1955
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic or recurrent cancer.

Conditions

Breast Cancer; Gastric Cancer; Lung Cancer; Ovarian Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

stage IV breast cancer; recurrent breast cancer; stage IV gastric cancer; recurrent gastric cancer; recurrent non-small cell lung cancer; stage IV ovarian epithelial cancer; recurrent ovarian epithelial cancer; adenocarcinoma of the stomach; stage IV non-small cell lung cancer; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Determine the optimum biologic dose of MVF-HER-2 (628-647)-CRL 1005 vaccine that will induce snit-HER-2 antibody in patients with metastatic or recurrent cancer

  baseline to 1 year

Secondary Outcomes (2)

• Characterize the nature and severity of toxicity of this drug in these patients.

  baseline to 1 year

• Document any clinical responses to this drug in these patients.

  baseline to 1 year

Study Arms (5)

Dose #1

EXPERIMENTAL

dose #1 administered

Biological: MVF-HER-2(628-647)-CRL 1005 vaccine

Dose #2

EXPERIMENTAL

dose #2 administered

Biological: MVF-HER-2(628-647)-CRL 1005 vaccine

Dose #3

EXPERIMENTAL

Dose #3 administered

Biological: MVF-HER-2(628-647)-CRL 1005 vaccine

Dose #4

EXPERIMENTAL

Dose #4 administered

Biological: MVF-HER-2(628-647)-CRL 1005 vaccine

Dose #5

EXPERIMENTAL

Administered dose #5

Biological: MVF-HER-2(628-647)-CRL 1005 vaccine

Interventions

MVF-HER-2(628-647)-CRL 1005 vaccine BIOLOGICAL

Dose #1; Dose #2; Dose #3; Dose #4; Dose #5

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed metastatic and/or recurrent solid tumor, especially the following: Breast Ovarian Non-small cell lung cancer Gastric adenocarcinoma No standard therapy available No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL ALT less than 2 times upper limit of normal No hepatitis A, B, or C Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No serious cardiopulmonary disorder No congestive heart failure No symptomatic coronary artery disease No serious cardiac arrhythmia Pulmonary: No serious cardiopulmonary disorder No symptomatic chronic obstructive pulmonary disease Immunologic: Reactive to at least 1 of the following skin test antigens: Candida, mumps, Trichophyton, intermediate strength PPD, tetanus toxoid No concurrent disease requiring corticosteroids or other immunosuppressive drugs No autoimmune disease, including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, or vasculitic syndrome No prior anaphylactic response to other vaccine No hypersensitivity to MVF-HER-2(628-647) Other: No active HIV No active infection requiring antibiotic therapy No serious medical disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: At least 4 weeks since prior cytotoxic chemotherapy and recovered Endocrine therapy: At least 4 weeks since prior hormonal therapy and recovered No concurrent corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: At least 4 weeks since prior surgery and recovered No prior splenectomy

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Breast Neoplasms; Stomach Neoplasms; Lung Neoplasms; Ovarian Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Pierre L. Triozzi, MD

  University of Alabama at Birmingham

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 6, 2001
• First Posted: January 8, 2004
• Study Start: March 1, 2000
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: August 5, 2013

Record last verified: 2012-11