Monoclonal Antibody Therapy in Treating Patients With Advanced Solid Tumors

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Anti-Idiotypic; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Immunoglobulins; Immunologic Factors; Mitogens

Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed solid tumor that is unresponsive to currently available therapies or for which no known effective treatment exists

• Measurable or evaluable disease

• Must have clinical or radiological evidence of disease

• Disease must be accessible to biopsy and imaging studies

• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count at least 2,000/mm^3

• Platelet count at least 100,000/mm^3

• No prior bleeding disorder

Hepatic

• Bilirubin no greater than 1.2 mg/dL

• alanine aminotransferase test (ALT) and Aspartate Aminotransferase (AST) no greater than 2.5 times upper limit of normal (ULN)

• Prothrombin time (PT)/ partial thromboplastin time (PTT) no greater than ULN

Renal

• Creatinine less than 1.5 mg/dL OR

• Creatinine clearance at least 60 mL/min

Cardiovascular

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after study

• Willing to be premedicated for delayed contrast-enhanced MRI

• No prior claustrophobia

• No dementia or altered mental status that would preclude informed consent

• No other uncontrolled concurrent illness

• No ongoing or active infection

• No psychiatric illness or social situations that would preclude study compliance

• No immunodeficiency

• HIV negative

• Must be willing to receive blood products

• No thyroid disease

• Thyroxine and thyroid-stimulating hormone no greater than ULN

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 4 weeks since prior immunotherapy

Exclusion Criteria Chemotherapy

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

• Prior taxanes allowed

• No concurrent chemotherapy

Endocrine therapy

• No concurrent hormonal therapy except:

• Concurrent hormonal replacement therapy

• Concurrent medication for maintaining castrate status in patients with progressive hormone refractory prostate cancer

Radiotherapy

• At least 4 weeks since prior radiotherapy and recovered

• No prior radiotherapy to more than 25% of the bone marrow

• No concurrent radiotherapy

Surgery

• More than 4 weeks since prior surgery

Other

• No other concurrent investigational or commercial agents or therapies for the malignancy

• No other concurrent antitumor therapy