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Monoclonal Antibody A1G4 Plus BCG in Treating Patients With Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center Identifier:
First received: November 1, 1999
Last updated: January 17, 2013
Last verified: January 2013

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.

Condition Intervention Phase
Biological: BCG vaccine
Biological: monoclonal antibody A1G4 anti-idiotype vaccine
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Trial of A1G4 Anti-Idiotypic Monoclonal Antibody With Bacille-Calmette-Guerin (BCG) Adjuvant in High Risk Patients With GD2 Positive Tumors

Resource links provided by NLM:

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Estimated Enrollment: 24
Study Start Date: March 1997
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00003023

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Nai-Kong V. Cheung, MD, PhD Memorial Sloan Kettering Cancer Center
  More Information Identifier: NCT00003023     History of Changes
Other Study ID Numbers: 97-024
P30CA008748 ( US NIH Grant/Contract Award Number )
Study First Received: November 1, 1999
Last Updated: January 17, 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
metastatic osteosarcoma
recurrent adult soft tissue sarcoma
disseminated neuroblastoma
stage 4S neuroblastoma
recurrent neuroblastoma
recurrent osteosarcoma
metastatic childhood soft tissue sarcoma
recurrent childhood soft tissue sarcoma
stage IV adult soft tissue sarcoma

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antibodies, Monoclonal
BCG Vaccine
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic processed this record on March 24, 2017