Monoclonal Antibody A1G4 Plus BCG in Treating Patients With Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00003023
First received: November 1, 1999
Last updated: January 17, 2013
Last verified: January 2013

November 1, 1999
January 17, 2013
March 1997
January 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003023 on ClinicalTrials.gov Archive Site
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Monoclonal Antibody A1G4 Plus BCG in Treating Patients With Cancer
Phase I Trial of A1G4 Anti-Idiotypic Monoclonal Antibody With Bacille-Calmette-Guerin (BCG) Adjuvant in High Risk Patients With GD2 Positive Tumors

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody A1G4 with BCG may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody A1G4 plus BCG in treating patients with cancer.

OBJECTIVES:

  • Assess the toxicity and feasibility of immunizing patients with anti-idiotypic rat monoclonal antibody A1G4 combined with Bacillus Calmette Guerin (BCG) adjuvant.
  • Determine whether immunization with A1G4 combined with BCG results in an immune response directed against GD2 ganglioside in patients.

OUTLINE: All patients are treated with A1G4 diluted in sterile physiologic saline mixed with Bacillus Calmette Guerin (BCG) organisms. The vaccine is injected intradermally in multiple sites. Booster immunizations are administered during weeks 2, 4, 8, 12, 20, 28, 36, 44, 52. Immunizations are not administered in limbs where draining lymph nodes have been surgically removed or previously irradiated. Isoniazid is administered for 5 days after each BCG injection. If severe skin reactions are present at the injection site, the BCG dose is decreased. If skin reactions persist, the BCG dose is stopped but A1G4 injections continue.

At least 6 patients are accrued at each dose level of A1G4. Dose escalation is not carried out until patients have been followed for at least 8 weeks after the first immunization without encountering grade 3 or worse non-skin toxicity.

If 0-1 patient experiences dose limiting toxicity (DLT) at a given dose level, then patients are accrued to the next higher dose level. If 2 or more patients experience DLT, the MTD is defined as the previous dose level.

Patients are followed for at least 1 year.

PROJECTED ACCRUAL: A total of 24 patients are expected to complete this study. If patients are removed early from the study prior to evaluation for serological response, additional patients will be accrued until 6 patients are evaluable for serological response.

Interventional
Phase 1
Primary Purpose: Treatment
  • Neuroblastoma
  • Sarcoma
  • Biological: BCG vaccine
  • Biological: monoclonal antibody A1G4 anti-idiotype vaccine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
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January 2005   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed GD2 positive tumors which include:

    • High risk neuroblastoma (stage IV, or N-myc amplified, or localized neuroblastoma multiply recurrent)
    • Recurrent or metastatic osteosarcoma
    • Recurrent or metastatic GD2 positive sarcomas
  • If free of disease, patient must be fully recovered from toxic effects or complications of prior treatments (chemotherapy or surgery)

    • No greater than 6 months since last chemotherapy or surgery before first injection of A1G4

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • Not specified

Life expectancy:

  • At least 6 months

Hematopoietic:

  • Absolute neutrophil count greater than 500/mm^3
  • Absolute leukocyte count greater than 500/mm^3
  • Peripheral T-cell phytohemagglutinin activation (PHA) at least 50% of normal

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • No significant heart disease (NYHA class III or IV)

Other:

  • No other serious intercurrent illnesses
  • No active infections requiring antibiotics
  • No active bleeding
  • No primary immunodeficiency
  • Not pregnant or nursing
  • Adequate contraception required of all fertile patients

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent antibiotics
  • No prior mouse antibodies and detectable human antimouse antibody (HAMA) titer

Chemotherapy:

  • See Disease Characteristics
  • At least 6 weeks since nitrosoureas
  • At least 4 weeks since other systemic chemotherapy

Endocrine therapy:

  • No concurrent nonsteroidal anti-inflammatory agents
  • No concurrent corticosteroid

Radiotherapy:

  • At least 4 weeks since radiotherapy
  • No prior radiation therapy to the spleen

Surgery:

  • See Disease Characteristics
  • No splenectomy
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003023
97-024, P30CA008748, MSKCC-97024, NCI-G97-1268
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Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Nai-Kong V. Cheung, MD, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP