Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Trial Contact Information

Alternate Title

BB-10901 in Treating Patients With Recurrent or Refractory Lung Cancer, Metastatic Carcinoid Tumor, or Other Solid Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Active 18 and over Other, Pharmaceutical / Industry BBIO-C10/IVB/001 EU-20318

Objectives

Primary

1. 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.
2. Determine the safety and tolerability of this drug in these patients.
3. Determine the efficacy of this drug in these patients.

Secondary

1. Determine the pharmacokinetics of this drug in these patients.

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³
• 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

Projected Accrual

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

Outline

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

• Phase I: 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.

Disclaimer

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Trial Contact Information

Trial Lead Organizations

British Biotech Pharmaceuticals Ltd.

Frank Vito Fossella, MD, Study coordinator		Ph: 713-792-6363; 800-392-1611

U.S.A.
Massachusetts
	Springfield
	Baystate Regional Cancer Program at Baystate Medical Center
		John McCann, MD	Ph:  413-794-3316
			Email: John.McCann@bhs.org
Texas
	Houston
	University of Texas - MD Anderson Cancer Center
		Frank Vito Fossella, MD	Ph:  713-792-6363 800-392-1611
	San Antonio
	San Antonio Cancer Institute
		Anthony Tolcher, MD	Ph:  210-616-5914

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