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SCH-900105 in Recurrent Glioblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01189513
Recruitment Status : Withdrawn (Sponsor decision.)
First Posted : August 26, 2010
Last Update Posted : February 20, 2012
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to find the highest tolerable dose of SCH 900105 that can be given to patients with glioblastoma before surgery. The safety of this drug will also be studied.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: SCH 900105 Phase 1

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Evaluation of SCH 900105 With Correlative Tissue Studies in the Treatment of Adult Patients With Recurrent Glioblastoma
Study Start Date : August 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SCH 900105
10 mg/kg intravenous Days 1, 8 and 15 of 30 day cycle.
Drug: SCH 900105
10 mg/kg by vein every week on days 1, 8 and 15 of a 30 day cycle.




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: 30 days for Cycle 1, and every 28 days for following cycles ]
    MTD of SCH 900105 defined as the dose level prior to that resulting in dose limiting toxicity (DLT i.e., the dose level at which no more than 1 out of 6 subjects experiences). DLT).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who have a diagnosis of supratentorial glioblastoma or gliosarcoma by pathology review after initial tumor resection and who have radiographic evidence of recurrent tumor.
  2. Eligibility will be restricted to patients in whom the clinical decision has been made to perform surgery at recurrence for symptom relief or for cytoreduction. Due to the requirement that SCH 900105 treatment will be given for 15 days prior to surgery, only patients who are determined to be not at risk from this delay in the best clinical judgment of the neurosurgeon, the treating neuro-oncologist and the study chair will be eligible for entry into the study.
  3. (2. continued) Patients who are in poor clinical condition as defined by Karnofsky performance status (KPS) or have progressive symptoms necessitating urgent surgery will be excluded from this study.
  4. Patients must have enhancing disease on the MRI scan sufficient to provide tissue samples for pathological diagnosis & correlative studies AND if the surgical plan includes resection of this part of the tumor. Patients with radiologically evident areas of tumor necrosis will be eligible for entry into this study if there is sufficient non-necrotic tumor to permit tissue correlative studies. The study chair will make a determination with the help of the treating physician, neuro-radiologist and neurosurgeon whether a particular patient fulfils the radiological requirements for study entry.
  5. Patients must have failed prior radiation therapy and must have an interval of greater than or equal to 12 weeks (84 Days) from the completion of radiation therapy to study entry.
  6. Patients may have had treatment for no more than 3 prior relapses. Relapse is defined as progression following initial therapy (i.e. radiation +/- chemo if that was used as initial therapy). The intent therefore is that patients had no more than 4 prior therapies (initial and treatment for 3 relapses). For patients who had prior therapy for a low-grade glioma, a prior surgical diagnosis of a high-grade glioma will be considered the first relapse.
  7. Patients must have recovered from the toxic effects of prior therapy at the time of initiation of the study drug: 4 weeks from any investigational agents, two weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, 3 weeks for temozolomide, 4 weeks for carboplatin, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, cis-retinoic acid, etc. (radiosensitizer does not count). Prior anti-angiogenic therapy is not allowed. For patients who have undergone radiation therapy (XRT), at least 12 weeks should have elapsed since completion of XRT.
  8. Patients must be equal to or greater than 18 years of age.
  9. All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must have signed an authorization for the release of their protected health information.
  10. Patients must have adequate bone marrow function (absolute granulocyte count >/= 1,500 and platelet count >/= 100,000), normal coagulation profile (PT/PTT), adequate liver function (SGPT, SGOT, and alkaline phosphatase </= 2.5 times normal and bilirubin < 1.5 mg/dL), adequate renal function (BUN or creatinine </= 1.5 times institutional normal) and institutional normal serum amylase within 14 days prior to starting therapy.
  11. Patients must have a Karnofsky performance status (KPS) of >/= 60.
  12. All patients (men and women) of childbearing potential must agree to use adequate birth control (barrier methods) during and for 1 month after participation in this study.
  13. Women of childbearing potential must have a negative Beta Human Chorionic Gonadotropin(B-HCG) pregnancy test documented within 14 days prior to registration.
  14. This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender.
  15. Archived paraffin embedded tissue (15 unstained slides) must be available for confirmation of tumor diagnosis and correlative studies prior to receiving the first dose of SCH 900105.

Exclusion Criteria:

  1. Patients who have been previously treated with c-Met inhibitors are ineligible for this study.
  2. Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.
  3. Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible.
  4. Patients must not have active infection or with a fever >/= 38.5°C within 3 days prior to the first dose of SCH 900105.
  5. Patients must not be pregnant/breast feeding during and for 1 month after participation in this study.
  6. Patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism.
  7. Patients on full-dose anticoagulants (e.g., warfarin, low molecular weight heparin) for the treatment of deep vein thrombosis(DVT), pulmonary emboli (PE), atrial fibrillation, myocardial infarction, or any other thromboembolic event are not eligible.
  8. No exclusion to this study will be based on race. Minorities will actively be recruited to participate. The malignant glioma patient population treated at MDACC over the past year is as follows: American Indian or Alaskan Native - 0; Asian or Pacific Islander - <2%; Black, not of Hispanic Origin - 3%; Hispanic - 6%; White, not of Hispanic Origin - 88%; Other or Unknown - 2%; Total - 100%
  9. The safety profile of SCH 900105 was not established in the pediatric population, Patients under age 18 will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189513


Sponsors and Collaborators
M.D. Anderson Cancer Center
Schering-Plough
Investigators
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Principal Investigator: John DeGroot, MD UT MD Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01189513    
Other Study ID Numbers: 2009-0576
First Posted: August 26, 2010    Key Record Dates
Last Update Posted: February 20, 2012
Last Verified: February 2012
Keywords provided by M.D. Anderson Cancer Center:
Recurrent Glioblastoma
Gliosarcoma
SCH 900105
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue