BB-10901 in Treating Patients With Recurrent or Refractory Lung Cancer, Metastatic Carcinoid Tumor, or Other Solid Tumors
This study is currently recruiting patients.
Sponsored by: |
British Biotech Pharmaceuticals |
Information provided by: |
National Cancer Institute (NCI) |
Purpose
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
|
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Carcinoid Tumors; Digestive Diseases; Endocrine Diseases; Lung Cancer; Respiratory Diseases
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I/II Study 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
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.
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
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
Performance status
Life expectancy
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
Location
and Contact
Information
Massachusetts Baystate Regional Cancer Program at Baystate Medical Center, Springfield,
Massachusetts,
01107,
United States; Recruiting
Texas San Antonio Cancer Institute, San Antonio,
Texas,
78229-3264,
United States; Recruiting
Anthony W. Tolcher, MD
210-616-5914
University of Texas - MD Anderson Cancer Center, Houston,
Texas,
77030-4009,
United States; Recruiting
Frank Vito Fossella, MD
713-792-6363
Study chairs or principal investigators
Frank Vito Fossella, MD, M.D. Anderson Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000343705; BBIO-C10/IVB/001; EU-20318
Record last reviewed:
November 2003
Record first received:
December 10, 2003
ClinicalTrials.gov Identifier:
NCT00074256Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-05