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

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. Identifier: NCT00481455
Recruitment Status : Completed
First Posted : June 1, 2007
Last Update Posted : November 25, 2008
Information provided by:
CASI Pharmaceuticals, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Recurrent Glioblastoma Multiforme Drug: Panzem NCD Drug: Temozolomide Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: Panzem NCD
2000 mg q8h, continuous dosing in 28 day cycles
Other Names:
  • 2-methoxyestradiol
  • 2ME2

Drug: Temozolomide
Fixed dose

Primary Outcome Measures :
  1. 6-month progression free survival and median overall survival for patients receiving at least one dose [ Time Frame: Every 2 cycles ]

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

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

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 identifier (NCT number): NCT00481455

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United States, North Carolina
The Brain Tumor Center, Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
CASI Pharmaceuticals, Inc.
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Principal Investigator: Annick Desjardins, MD Duke University
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Responsible Party: Chief Medical Officer, EntreMed, Inc Identifier: NCT00481455    
Other Study ID Numbers: ME-CLN-007
First Posted: June 1, 2007    Key Record Dates
Last Update Posted: November 25, 2008
Last Verified: November 2008
Keywords provided by CASI Pharmaceuticals, Inc.:
Glioblastoma Multiforme
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators