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Phase I Trial of A1G4 Anti-Idiotypic Monoclonal Antibody With Bacille-Calmette-Guerin (BCG) Adjuvant in High Risk Patients With GD2 Positive Tumors


Phase 1
N/A
N/A
Not Enrolling
Both
Neuroblastoma, Sarcoma

Thank you

Trial Information

Phase I Trial of A1G4 Anti-Idiotypic Monoclonal Antibody With Bacille-Calmette-Guerin (BCG) Adjuvant in High Risk Patients With GD2 Positive Tumors


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Nai-Kong V. Cheung, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

97-024

NCT ID:

NCT00003023

Start Date:

March 1997

Completion Date:

Related Keywords:

  • Neuroblastoma
  • Sarcoma
  • 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
  • Neuroblastoma
  • Sarcoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021