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BB-10901 in Treating Patients With Relapsed or Refractory Solid Tumors

Primary Purpose

Ovarian Cancer, Merkel Cell Carcinoma, SCLC

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BB-10901
Sponsored by
ImmunoGen, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent small cell lung cancer, merkel cell carcinoma, ovarian cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS During Dose Escalation: Histologically or cytologically confirmed diagnosis of 1 of the following: Small cell lung cancer (SCLC) Other pulmonary tumors of neuroendocrine origin, including neuroendocrine carcinoma or non-SCLC with neuroendocrine features Non-pulmonary small cell carcinoma Metastatic carcinoid tumor Other CD56-positive solid tumor Diagnoses other than SCLC must have confirmation of tumor CD56 expression before study entry Relapsed or refractory disease Must have received at least 1 but no more than 3 prior chemotherapy regimens* and recovered from any acute toxicities No prior chemotherapy for carcinoid or neuroendocrine tumors DISEASE CHARACTERISTICS During MTD Expansion: Relapsed or refractory Small cell lung cancer (SCLC) Metastatic Merkel Cell carcinomas Ovarian carcinomas At the MTD: SCLC patients must have received one, but no more than 1 prior chemotherapy regimen Merkel and Ovarian patients must have received at least one prior chemotherapy regimen. Ovarian patients must have received at least one platinum-based regimen. Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan No uncontrolled carcinoid syndrome (e.g., flushing, uncontrolled diarrhea, labile blood pressure) No active brain metastases; no evidence of active disease and no requirement for anticonvulsant medications or steroids. PATIENT CHARACTERISTICS: Life expectancy ≥ 3 months ECOG performance status 0-2 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10 g/dL Creatinine ≤ 1.5 times upper limit of normal (ULN) AST and ALT ≤ 2.5 times ULN Bilirubin ≤ 3 times ULN No rapidly rising liver function tests (LFTs) Pancreatic function, amylase and lipase within upper limit of normal. No significant residual neurological or cardiac toxicity ≥ grade 2 after prior chemotherapy No myocardial infarction within the past 6 months No unstable angina pectoris No uncontrolled congestive heart failure No uncontrolled arrhythmia No severe aortic stenosis No history of multiple sclerosis or other demyelinating disease No Eaton-Lambert syndrome (para-neoplastic syndrome) No history of hemorrhagic stroke No CNS injury with residual neurologic deficit No ischemic stroke within the past 6 months No history of pancreatitis No current active infection or history of recurrent infection with varicella-zoster virus (shingles) or cytomegalovirus No other concurrent serious infection No chronic alcoholism No other concurrent illness or condition that would interfere with study outcome No other malignancy within the past 3 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix No known recent biochemical or clinical evidence of pancreatitis or extensive metastatic disease involving the pancreas PRIOR CONCURRENT THERAPY: See Disease Characteristics Total cumulative dosage of prior anthracycline treatment must not exceed threshold for cardiotoxicity No known hypersensitivity to previous monoclonal antibody therapy More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy More than 4 weeks since prior and no other concurrent investigational agents At least 4 weeks since prior and no concurrent surgery No other concurrent antineoplastic treatment, including immunotherapy or steroid therapy

Sites / Locations

  • University of California San Francisco
  • Nevada Cancer Institute
  • The Ohio State University Cancer Center and Research Institute
  • Oklahoma University
  • M. D. Anderson Cancer Center at University of Texas
  • Fred Hutchinson Cancer Research Center
  • Christie Hospital NHS Trust
  • Cancer Research Centre at Weston Park Hospital
  • Royal Marsden NHS Foundation Trust - Surrey

Outcomes

Primary Outcome Measures

Safety and tolerability assessed by toxicity evaluation and prothrombin time assessments

Secondary Outcome Measures

Pharmacokinetics assessed by measuring intact conjugate and total huN901 antibody concentration for each time point and dose level
Efficacy assessed by measuring response (complete or partial response) and biomarker levels of neuron-specific enolase and soluble neural cell adhesion molecules (NCAM)

Full Information

First Posted
June 28, 2006
Last Updated
March 24, 2015
Sponsor
ImmunoGen, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00346385
Brief Title
BB-10901 in Treating Patients With Relapsed or Refractory Solid Tumors
Official Title
A Phase I, Open-Label, Dose Escalation Study of Daily Dosing With BB-10901
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmunoGen, Inc.

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Monoclonal antibodies, such as BB-10901, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase I trial is studying the side effects and best dose of BB-10901 in treating patients with relapsed or refractory solid tumors.
Detailed Description
OBJECTIVES: Primary Determine the safety and tolerability of BB-10901 Determine the maximum tolerated dose of this drug in these patients. Secondary Determine the pharmacokinetics of this drug in these patients. Determine the efficacy of this drug in these patients. OUTLINE: This is an open-label, multicenter, dose-escalation study. Patients receive BB-10901 IV over 40 minutes once daily on days 1-3.* Treatment repeats every 21 days NOTE: *Patients who do not tolerate 3 consecutive daily infusions of BB-10901 may receive infusions of BB-10901 on 3 alternate days, upon approval by the investigator and/or the independent Safety Review Board. Cohorts of 4-6 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 4-6 patients experience dose-limiting toxicity in course 1. Up to 40 patients are treated at the MTD. After completion of study treatment, patients are followed for short term and long term follow up and survival. PROJECTED ACCRUAL: Approximately 100 patients will be accrued to this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Merkel Cell Carcinoma, SCLC
Keywords
recurrent small cell lung cancer, merkel cell carcinoma, ovarian cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BB-10901
Other Intervention Name(s)
IMGN901
Intervention Description
dose escalation study, dose will vary per cohort. patients will receive an IV infusion once every three weeks.
Primary Outcome Measure Information:
Title
Safety and tolerability assessed by toxicity evaluation and prothrombin time assessments
Time Frame
these tests will be conducted at various timepoints during a patients participation in the trial
Secondary Outcome Measure Information:
Title
Pharmacokinetics assessed by measuring intact conjugate and total huN901 antibody concentration for each time point and dose level
Time Frame
PK is assessed during the first cycle (21 days) of a patients participation
Title
Efficacy assessed by measuring response (complete or partial response) and biomarker levels of neuron-specific enolase and soluble neural cell adhesion molecules (NCAM)
Time Frame
efficacy is assessed every 2 cycles during a patients participation while other blood tests are taken during every cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS During Dose Escalation: Histologically or cytologically confirmed diagnosis of 1 of the following: Small cell lung cancer (SCLC) Other pulmonary tumors of neuroendocrine origin, including neuroendocrine carcinoma or non-SCLC with neuroendocrine features Non-pulmonary small cell carcinoma Metastatic carcinoid tumor Other CD56-positive solid tumor Diagnoses other than SCLC must have confirmation of tumor CD56 expression before study entry Relapsed or refractory disease Must have received at least 1 but no more than 3 prior chemotherapy regimens* and recovered from any acute toxicities No prior chemotherapy for carcinoid or neuroendocrine tumors DISEASE CHARACTERISTICS During MTD Expansion: Relapsed or refractory Small cell lung cancer (SCLC) Metastatic Merkel Cell carcinomas Ovarian carcinomas At the MTD: SCLC patients must have received one, but no more than 1 prior chemotherapy regimen Merkel and Ovarian patients must have received at least one prior chemotherapy regimen. Ovarian patients must have received at least one platinum-based regimen. Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan No uncontrolled carcinoid syndrome (e.g., flushing, uncontrolled diarrhea, labile blood pressure) No active brain metastases; no evidence of active disease and no requirement for anticonvulsant medications or steroids. PATIENT CHARACTERISTICS: Life expectancy ≥ 3 months ECOG performance status 0-2 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10 g/dL Creatinine ≤ 1.5 times upper limit of normal (ULN) AST and ALT ≤ 2.5 times ULN Bilirubin ≤ 3 times ULN No rapidly rising liver function tests (LFTs) Pancreatic function, amylase and lipase within upper limit of normal. No significant residual neurological or cardiac toxicity ≥ grade 2 after prior chemotherapy No myocardial infarction within the past 6 months No unstable angina pectoris No uncontrolled congestive heart failure No uncontrolled arrhythmia No severe aortic stenosis No history of multiple sclerosis or other demyelinating disease No Eaton-Lambert syndrome (para-neoplastic syndrome) No history of hemorrhagic stroke No CNS injury with residual neurologic deficit No ischemic stroke within the past 6 months No history of pancreatitis No current active infection or history of recurrent infection with varicella-zoster virus (shingles) or cytomegalovirus No other concurrent serious infection No chronic alcoholism No other concurrent illness or condition that would interfere with study outcome No other malignancy within the past 3 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix No known recent biochemical or clinical evidence of pancreatitis or extensive metastatic disease involving the pancreas PRIOR CONCURRENT THERAPY: See Disease Characteristics Total cumulative dosage of prior anthracycline treatment must not exceed threshold for cardiotoxicity No known hypersensitivity to previous monoclonal antibody therapy More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy More than 4 weeks since prior and no other concurrent investigational agents At least 4 weeks since prior and no concurrent surgery No other concurrent antineoplastic treatment, including immunotherapy or steroid therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul C. Lorigan, MD
Organizational Affiliation
The Christie NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
The Ohio State University Cancer Center and Research Institute
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Oklahoma University
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
M. D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
Facility Name
Christie Hospital NHS Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 9BX
Country
United Kingdom
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

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BB-10901 in Treating Patients With Relapsed or Refractory Solid Tumors

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