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A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing With BB-10901, Followed by a Phase II Efficacy Expansion

Phase 1/Phase 2
18 Years
Not Enrolling
Small Cell Lung Cancer

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Trial Information

A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing With BB-10901, Followed by a Phase II Efficacy Expansion

The Phase II efficacy expansion was restricted to SCLC patients with relapsed disease and
the MTD was determined by the Phase I portion of the trial (60mg/m2).

Inclusion Criteria


- Histologically or Cytologically proven SCLC, CD 56+ small cell carcinoma of unknown
origin, or CD56+ non-pulmonary small cell carcinoma

- Relapsed disease; defined as patients with an initial response (partial or complete)
to first-line therapy, then relapse more than 3 months after completion of last

- Patients must have received no more than 3 prior chemotherapy regimen.

- Patients must have measurable disease defined as: Lesions that can be measured in at
least one dimension according to RECIST

- Predicted survival of 3 months or more

- Zubrod performance status 0-2

- Patients must not have received chemotherapy or radiation therapy within 4 weeks of
study entry, nor have planned surgery.

- Absolute neutrophils greater than or equal to 1.5 x 10^9/l, hemoglobin greater than
or equal to 9g/dl and platelets greater than or equal to 100 x 10^9/l.

- Creatinine less than or equal to 1.5 times the upper limit of normal

- AST/ALT less than or equal to 3 times the upper limit of normal without liver
metastases; less than or equal to 5 times the upper limit of normal with liver
metastases and bilirubin less than or equal to 1.5 times the upper limit of normal.

- Patients must have normal thyroid function (patients receiving thyroxin replacement
therapy who are biochemically euthyroid may be enrolled).

- Women of childbearing potential must provide a negative pregnancy test at screening
and use adequate contraception in the opinion of the investigator, for the duration
of study.

- Patients must be capable of understanding the nature of the trial and must give
written witnessed informed consent prior to any screening procedure.


- Significant residual neurological or cardiac toxicity (grade 3 or 4) following
previous chemotherapy

- Patients who are concurrently receiving other anti-neoplastic treatment
(chemotherapy, radiotherapy, or immunotherapy including steroid therapy).

- Myocardial infarction within 6 months of study entry, unstable angina pectoris,
uncontrolled congestive heart failure, uncontrolled arrythmia, severe aortic
stenosis, a history of multiple sclerosis, or other demyelinating disease,
Eaton-Lambert Syndrome, history of hemorrhagic stroke, any CNS injury with residual
neurologic deficit, ischaemic stroke within the last 6 months, current known herpes
zoster (shingles), or cytomegalovirus infection, or a history of recurrent infections
with these viruses, chronic alcoholism, serious concomitant infection, or any other
concomitant illness considered significant enough to interfere with the study

- Other investigational agents must not be taken during the study or within 4 weeks of
study entry.

- Previous monoclonal antibody therapy

- Patients must not have known central nervous system metastases

- Previous malignancy with < 5 year disease free interval from the last therapeutic
intervention, except for adequately treated basal cell carcinoma of the skin or
carcinoma in situ of the cervix.

- Patient unwilling or unable to tolerate and comply with the requirements of the

- Pregnant or lactating females.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I Toxicity Based Upon Adverse Events Clasified by the NCI Common Terminology Ctireria Version 2.0 (Phase I)

Outcome Description:

Dose limiting toxicities graded according to common terminology criteria for advers events, version 2.0 and defined as AEs (probably/definitely related to study drug) meeting the NCI CTC criteria, assessed on the basis of the first cycle of therapy (4 weeks of weekly dosing/2 week fu): Hematologic Tox (Grade 4 neutropenia ≥ 5 days, Grade 4 thrombocytopenia, neutropenic infection); Non-Hem Toxicity: (Any grade 3 or 4 non-hematologic toxicity, excluding nausea, vomiting, diarrhea and alopecia); Toxicity present at Screening (concurrent conditions), an increase in severity of 2 or more grades.

Outcome Time Frame:

every 6 weeks

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2003

Completion Date:

December 2008

Related Keywords:

  • Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



MD Anderson Cancer Center Houston, Texas  77030-4096
Baystate Medical Center Springfield, Massachusetts  01199
Virginia Oncology Associates Newport News, Virginia  23606
Cancer Centers of the Carolinas Greenville, South Carolina  29605
Rocky Mountain Cancer Centers Thornton, Colorado  80260
Tyler Cancer Center Tyler, Texas  75702
Northwest Cancer Specialists Vancouver, Washington  98664
The Ohio State University Columbus, Ohio  43210
New York Oncology Hematology Albany, New York  12208
Cancer Center of Florida Ocoee, Florida  34761
Greater Dayton Cancer Center Kettering, Ohio  45409