Phase I Trial of A1G4 Anti-Idiotypic Monoclonal Antibody With Bacille-Calmette-Guerin (BCG) Adjuvant in High Risk Patients With GD2 Positive Tumors
BCG vaccine
+ monoclonal antibody A1G4 anti-idiotype vaccine
Neoplasms+12
+ Neoplasms by Histologic Type
+ Neoplasms, Connective Tissue
Treatment Study
Summary
Study start date: March 1, 1997
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Memorial Sloan-Kettering Cancer Center
New York, United StatesOpen Memorial Sloan-Kettering Cancer Center in Google Maps