Status:
TERMINATED
Randomized Efficacy Study of TPI 287 to Treat Primary Refractory or Early Relapsed Neuroblastoma
Lead Sponsor:
Giselle Sholler
Collaborating Sponsors:
Cortice Biosciences, Inc.
Conditions:
Neuroblastoma
Eligibility:
All Genders
12-21 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this research study is to evaluate a new investigational drug (TPI 287) for early relapsed neuroblastoma. An investigational drug is one that has not yet been approved by the Food and D...
Eligibility Criteria
Inclusion
- Subjects must have histologically proven Neuroblastoma and confirmation of primary refractory or recurrent disease with histologic confirmation at diagnosis or at the time of recurrence/progression. Subjects must have primary refractory or have early relapse disease (early relapse disease is defined as having received ≤ one or two relapse therapies).
- Subjects must be age \>12 months and diagnosed before the age of 21 years
- Measurable disease, including at least one of the following:
- Measurable tumor \>10 mm by CT or MRI Positive bone marrow biopsy/aspirate Positive MIBG
- Current disease state must be one for which there is currently no known curative therapy
- Lansky Play Score or Karnofsky scale must be more than 30
- Subjects without bone marrow metastases must have an ANC \> 750/μl and platelet count \>50,000/μl
- Adequate Renal Function Defined As Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 or
- A serum creatinine based on age/gender table
- Adequate liver function must be demonstrated, defined as:
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age SGPT (ALT) \< 10 x upper limit of normal (ULN) for age SGOT (AST) \< 10x upper limit of normal (ULN) for age
- No other significant organ toxicity defined as \>Grade 2 by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE V4.0- http://ctep.cancer.gov/forms/CTCAEv4.pdf)
- A negative urine pregnancy test is required for female participants of child bearing potential (≥13 years of age or after onset of menses)
- Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives ("the pill"), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
- Informed Consent: All subjects and/or legal guardians must sign written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines
- Subjects may have received microtubulin inhibitors during previous therapies.
- Subjects may have received any number of prior biological therapies.
Exclusion
- Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from the effects of prior chemotherapy (hematological and bone marrow suppression effects), generally at least 3 weeks from the most recent administration (6 weeks for nitrosoureas). Subjects may not have received more than 1 cycle of Irinotecan and Temozolomide as previous relapse therapy.
- Subjects who have received any myeloablative therapy within the previous 2 months.
- Subjects receiving any investigational drug concurrently
- Subjects with serious infection or a life-threatening illness (unrelated to tumor) that is \> Grade 2 (NCI CTCAE V4.0), or active, serious infections requiring parenteral antibiotic therapy.
- Subjects with any other medical condition, including malabsorption syndromes, mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the interpretation of the results or which would interfere with a subject's ability to sign or the legal guardian's ability to sign the informed consent, and subject's ability to cooperate and participate in the study
- Subjects with known hypersensitivity to any of the components of the drugs to be administered on study.
- Subjects who have previously been treated with TPI 287.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01505608
Start Date
December 1 2011
End Date
December 1 2014
Last Update
August 6 2024
Active Locations (8)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States
2
Rady Children's Hospital
San Diego, California, United States, 92123
3
Connecticut Children's Hospital
Hartford, Connecticut, United States, 06106
4
Arnold Palmer Hospital for Children- MD Anderson
Orlando, Florida, United States, 32806