Phase I Trial of A1G4 Anti-Idiotypic Monoclonal Antibody With Bacille-Calmette-Guerin (BCG) Adjuvant in High Risk Patients With GD2 Positive Tumors
- 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.
Primary Purpose: Treatment
Nai-Kong V. Cheung, MD, PhD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|