Phase 2 Study of Panzem Nanocrystal Colloidal Dispersion (NCD) in Combination With Fixed-Dose Temozolomide to Patients With Recurrent Glioblastoma Multiforme (GBM)

This study has been completed.
Sponsor:
Information provided by:
CASI Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00481455
First received: May 30, 2007
Last updated: November 24, 2008
Last verified: November 2008
  Purpose

The purpose of this study is to evaluate the anti-tumor activity and safety of Panzem NCD given in combination with daily oral fixed-dose temozolomide in patients with recurrent glioblastoma multiforme.


Condition Intervention Phase
Recurrent Glioblastoma Multiforme
Drug: Panzem NCD
Drug: Temozolomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-Center, Open-Label, Phase II, Safety and Efficacy Study of Panzem Nanocrystal Colloidal Dispersion Administered Orally in Combination With Protracted Oral Fixed-Dose Temozolomide to Patients With Recurrent Glioblastoma Multiforme

Resource links provided by NLM:


Further study details as provided by CASI Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 6-month progression free survival and median overall survival for patients receiving at least one dose [ Time Frame: Every 2 cycles ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: April 2007
Study Completion Date: October 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Panzem NCD
2000 mg q8h, continuous dosing in 28 day cycles
Other Names:
  • 2-methoxyestradiol
  • 2ME2
Drug: Temozolomide
Fixed dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A histologically confirmed diagnosis of a recurrent/progressive primary WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma). Patients with recurrent disease whose diagnostic pathology confirmed WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma) will not need re-biopsy. Patients with prior low-grade glioma are eligible if histologic assessment demonstrates transformation to WHO grade IV malignant glioma. Pathology must be confirmed at Duke University Medical Center
  2. Male or female, aged greater than or equal to 18 years.
  3. An interval of at least 2 weeks between prior surgical resection (if conducted) or any major surgery or 4 weeks between prior radiotherapy or chemotherapy (except nitrosoureas which require 6 weeks) and enrollment in this protocol unless there is unequivocal evidence of tumor progression and the patient has recovered from toxicities associated with those therapies. However, patients treated with chemotherapeutic agents such as VP-16 who would normally be retreated after shorter intervals (e.g. 21 days on, 7 days off schedule) may be treated at the usual starting time even if less than 4 weeks from the last prior dose of chemotherapy.
  4. Karnofsky performance score greater than or equal to 70%.
  5. Hematocrit > 29%, absolute neutrophil count > 1,500 cells/*L, platelets > 100,000 cells/*L.
  6. Serum creatinine < 1.5 X upper limit of normal (ULN), serum glutamic oxaloacetic transaminase < 2.5 X ULN; and bilirubin < 1.5 times ULN.
  7. Signed informed consent form and authorization for use and disclosure of protected health information approved by the Institutional Review Board (IRB) prior to patient entry.
  8. If sexually active, patients must use contraceptive measures for the duration of the treatments and for 4 weeks following end of study medication.

Exclusion Criteria:

  1. Current, active systemic bleeding or excessive risk of bleeding as defined by the following: stroke within the previous 6 months, history of central nervous system or intraocular bleed, history of septic endocarditis or evidence of intratumor hemorrhage on pretreatment diagnostic imaging, except for stable post operative grade 1 hemorrhage.
  2. Female patients who are pregnant or breastfeeding or adults of reproductive potential not employing an effective method of birth control. (Women of childbearing potential must have a negative pregnancy test within 48 hours prior to administration of study medication).
  3. Concurrent severe and/or uncontrolled medical disease (i.e. uncontrolled diabetes, congestive cardiac failure, myocardial infarction within 6 months, poorly controlled hypertension, history of labile hypertension, history of poor compliance with antihypertensive regimen, chronic renal disease, or active uncontrolled infection) that could compromise participation in the study.
  4. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study medication (i.e. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, bowel obstruction, or inability to swallow the liquid).
  5. Requirement for therapy with coumadin (warfarin sodium).
  6. Patient is < 1 year free of another primary malignancy except if the other primary malignancy is not currently clinically significant or requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
  7. Patients unwilling to or unable to comply with the protocol.
  8. Grade 2 or greater peripheral sensory neuropathy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481455

Locations
United States, North Carolina
The Brain Tumor Center, Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
CASI Pharmaceuticals, Inc.
Investigators
Principal Investigator: Annick Desjardins, MD Duke University
  More Information

No publications provided

Responsible Party: Chief Medical Officer, EntreMed, Inc
ClinicalTrials.gov Identifier: NCT00481455     History of Changes
Other Study ID Numbers: ME-CLN-007
Study First Received: May 30, 2007
Last Updated: November 24, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by CASI Pharmaceuticals, Inc.:
Glioblastoma Multiforme
temozolomide

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
2-methoxyestradiol
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on September 16, 2014