RATIONALE: Monoclonal antibodies such as BB-10901 can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I/II trial to study the effectiveness of BB-10901 in treating patients who have recurrent or refractory lung cancer, metastatic carcinoid tumor, or other solid tumors.

Condition	Treatment or Intervention	Phase
adult solid tumor gastrointestinal carcinoid tumor Neuroendocrine Carcinoma Non-small cell lung cancer pulmonary carcinoid tumor Small Cell Lung Cancer	Drug: BB-10901  Procedure: antibody conjugate therapy  Procedure: antibody therapy  Procedure: biological response modifier therapy	Phase I Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine the maximum tolerated dose of BB-10901 in patients with recurrent or refractory small cell lung cancer, other pulmonary tumors of neuroendocrine origin, non-pulmonary small cell carcinoma, metastatic carcinoid tumor, or other CD56+ solid tumors.
• Determine the safety and tolerability of this drug in these patients.
• Determine the efficacy of this drug in these patients.

Secondary

• Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is an open-label, dose-escalation, multicenter study.

• Patients receive BB-10901 IV over 2 hours once weekly for 4 weeks. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients who show evidence of response after 4 courses may receive additional treatment for up to a total of 6 courses. Cohorts of 3-6 patients receive escalating doses of BB-10901 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
• Phase II: Patients receive BB-10901 IV over 2 hours at the MTD determined in phase I. Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 82 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed diagnosis of 1 of the following:
• Small cell lung cancer (SCLC) (phase I and II)
• Other pulmonary tumor of neuroendocrine origin*, including neuroendocrine carcinoma and non-small cell lung cancer with neuroendocrine features
• Non-pulmonary small cell carcinoma*
• Metastatic carcinoid tumor*
• Other CD56+ solid tumor* NOTE: *Phase I only
• Diagnoses other than SCLC must have confirmation of tumor CD56 expression before study entry
• Relapsed or refractory, defined as the following:
• Relapsed (phase I and II):
• Initially responded (partial or complete) to first-line therapy and then relapsed more than 3 months after completion of the last chemotherapy regimen
• Refractory (phase I only):
• Failed to respond to or relapsed within 3 months of completion of the last chemotherapy regimen
• Unidimensionally measurable disease
• At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• No uncontrolled carcinoid syndrome (e.g., flushing, uncontrolled diarrhea, or labile blood pressure)
• No known CNS metastases

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• Zubrod 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 9 g/dL

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST/ALT no greater than 3 times ULN (5 times ULN if liver metastases are present)

Renal

• Creatinine no greater than 1.5 times ULN

Cardiovascular

• No grade 3 or 4 cardiac toxicity after prior chemotherapy
• No myocardial infarction within the past 6 months
• No ischemic stroke within the past 6 months
• No unstable angina pectoris
• No uncontrolled congestive heart failure
• No uncontrolled arrhythmia
• No severe aortic stenosis
• No history of hemorrhagic stroke

Neurologic

• No grade 3 or 4 neurological toxicity after prior chemotherapy
• No history of multiple sclerosis or other demyelinating disease
• No CNS injury with residual neurologic deficit
• No Eaton-Lambert syndrome (para-neoplastic syndrome)

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Able and willing to tolerate and comply with study requirements
• No chronic alcoholism
• No other malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
• No concurrent herpes zoster (shingles) or cytomegalovirus infection or history of recurrent infection with these viruses
• No concurrent serious infection
• No other concurrent significant illness that would preclude study outcome

PRIOR CONCURRENT THERAPY: Biologic therapy

• No prior monoclonal antibody therapy
• No other concurrent antineoplastic immunotherapy

Chemotherapy

• See Disease Characteristics
• More than 4 weeks since prior chemotherapy
• No more than 3 prior chemotherapy regimens (phase I)
• No more than 1 prior chemotherapy regimen (phase II)
• No concurrent antineoplastic chemotherapy

Endocrine therapy

• No concurrent antineoplastic steroid therapy

Radiotherapy

• More than 4 weeks since prior radiotherapy
• No concurrent antineoplastic radiotherapy

Surgery

• No concurrent surgery, including elective surgery

Other

• More than 4 weeks since other prior investigational agents
• No other concurrent antineoplastic treatment
• No other concurrent investigational agents

Massachusetts
      Baystate Regional Cancer Program at D'Amour Center for Cancer Care, Springfield,  Massachusetts,  01107,  United States; Recruiting
Texas
      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4009,  United States; Recruiting
      San Antonio Cancer Institute, San Antonio,  Texas,  78229-3264,  United States; Recruiting

Study chairs or principal investigators

Frank Vito Fossella, MD,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000343705; BBIO-C10/IVB/001; EU-20318; NCT00074256
Record last reviewed:  November 2003
Last Updated:  February 4, 2005
Record first received:  December 10, 2003
ClinicalTrials.gov Identifier:  NCT00074256
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08