Monoclonal Antibody A1G4 Plus BCG in Treating Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003023
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 18, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

November 1, 1999
January 27, 2003
January 18, 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 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.


  • 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.

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 Identifier (NCT Number) in Medline.
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January 2005   (Final data collection date for primary outcome measure)


  • 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



  • Any age

Performance status:

  • Not specified

Life expectancy:

  • At least 6 months


  • 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


  • Not specified


  • Not specified


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


  • 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


Biologic therapy:

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


  • 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


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


  • See Disease Characteristics
  • No splenectomy
Sexes Eligible for Study: All
Child, Adult, Older Adult
Contact information is only displayed when the study is recruiting subjects
United States
P30CA008748 ( U.S. NIH Grant/Contract )
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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