Ovarian Cancer Clinical Trial
Official title:
A Phase I, Open-Label, Dose Escalation Study of Daily Dosing With BB-10901
Verified date | March 2015 |
Source | ImmunoGen, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 97 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Christie Hospital NHS Trust | Manchester | England |
United Kingdom | Cancer Research Centre at Weston Park Hospital | Sheffield | England |
United Kingdom | Royal Marsden NHS Foundation Trust - Surrey | Sutton | England |
United States | The Ohio State University Cancer Center and Research Institute | Columbus | Ohio |
United States | M. D. Anderson Cancer Center at University of Texas | Houston | Texas |
United States | Nevada Cancer Institute | Las Vegas | Nevada |
United States | Oklahoma University | Oklahoma City | Oklahoma |
United States | University of California San Francisco | San Francisco | California |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
ImmunoGen, Inc. |
United States, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability assessed by toxicity evaluation and prothrombin time assessments | these tests will be conducted at various timepoints during a patients participation in the trial | Yes | |
Secondary | Pharmacokinetics assessed by measuring intact conjugate and total huN901 antibody concentration for each time point and dose level | PK is assessed during the first cycle (21 days) of a patients participation | No | |
Secondary | Efficacy assessed by measuring response (complete or partial response) and biomarker levels of neuron-specific enolase and soluble neural cell adhesion molecules (NCAM) | efficacy is assessed every 2 cycles during a patients participation while other blood tests are taken during every cycle | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Withdrawn |
NCT05201001 -
APX005M in Patients With Recurrent Ovarian Cancer
|
Phase 2 | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06376253 -
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
|
Phase 1 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT05156892 -
Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer
|
Phase 1 | |
Suspended |
NCT02432378 -
Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines
|
Phase 1/Phase 2 | |
Recruiting |
NCT04533763 -
Living WELL: A Web-Based Program for Ovarian Cancer Survivors
|
N/A | |
Active, not recruiting |
NCT03371693 -
Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer
|
Phase 3 | |
Withdrawn |
NCT03032614 -
Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients
|
Phase 2 | |
Completed |
NCT02019524 -
Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients
|
Phase 1 | |
Completed |
NCT01936363 -
Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer
|
Phase 2 | |
Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05059522 -
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
|
Phase 3 | |
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Terminated |
NCT04586335 -
Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
|
Phase 1 | |
Terminated |
NCT03146663 -
NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
|
Phase 2 |