Open-Label Study of TPI 287 for Patients With Metastatic Melanoma

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Cortice Biosciences, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01340729
First received: April 20, 2011
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

The goal of this clinical research study is to find the highest tolerable dose of TPI 287 that can be given to patients with metastatic melanoma. Researchers want to find out if TPI 287 can control the disease. The safety of TPI 287 will also be studied.


Condition Intervention Phase
Metastatic Melanoma
Drug: TPI 287
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Open-Label Study of TPI 287 for Patients With Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) TPI 287 administered weekly for three weeks out of every four in patients with metastatic melanoma [ Time Frame: With each 28 day cycle and DLTs at 12 weeks ] [ Designated as safety issue: Yes ]
    Optimal dose (MTD) of TPI 287 for the Phase II part of the study defined as level at which no dose limiting toxicities (DLTs) are experienced (3+3 dose escalation algorithm). DLT is defined as Grade 3 or higher toxicity that is reasonably likely to be associated with study treatment at 12 weeks.


Enrollment: 0
Study Start Date: September 2013
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TPI 287
Starting dose TPI 287 of 125 mg/m2 intravenous (IV) for 3 weeks of 4 week schedule.
Drug: TPI 287
Starting dose of 125 mg/m2 IV via a central venous catheter (CVC) or a peripherally inserted central catheter (PICC) line over 60 minutes (+/- 10 minutes) on Days 1, 8, and 15 (+/- 2 days) of each 28 day (+/- 3 days) study cycle. The 4-week schedule composes one cycle.

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  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histologically proven melanoma with metastasis that is unresectable Stage III or Stage IV. This will include bulky stage III and M1-3.
  2. Patients must have shown unequivocal evidence for tumor recurrence or progression and should have at least one indicator lesion that can be measured in one dimension as >/= 20mm with conventional techniques (CT, MRI, and X-ray) or >/= 10mm with spiral CT scan.
  3. Patients with melanoma with documented metastases to the brain are eligible: a. Must be asymptomatic with stable disease for at least 2 months as determined by CT or MRI of the brain at the time of evaluation no measurable changes. b. May have had prior therapy for brain metastasis such as whole brain irradiation, stereotactic gamma ray therapy or resection of brain metastases.
  4. Patients may have had up to two prior cytotoxic chemotherapy regimens for their systemic disease (immunological or targeted therapy e.g. vaccine, IL-2, B-RAF inhibitors, will not be considered prior cytotoxic chemotherapy)
  5. All patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of this hospital.
  6. Patients must have a Eastern Cooperative Oncology Group (ECOG) status of </= 2.
  7. Patients must have recovered from the toxic effects of prior therapy (baseline grade), at least 3 weeks after the last dose was administered. Any questions about whether patients fulfill this criteria should be directed to the Study Chair.
  8. Patients must have adequate bone marrow function (Absolute neutrophil count (ANC)>/= 1,500/mm^3 and platelet count of >/= 100,000/mm^3), adequate liver function [aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT or SGPT) </= 2.5 times normal for patients without liver metastasis and ALT (SGPT) and AST (SGOT) </= 5, times normal for patients with liver metastasis], serum bilirubin </= 2 mg/dl), and adequate renal function (BUN and creatinine >/= 1.5 times institutional normal) prior to starting therapy
  9. As TPI 287 may interfere with Coumadin dosing, patients who are taking TPI 287 will require monitoring of their Prothrombin Time (PT), Partial thromboplastin time (PTT) and International Normalized Ratio (INR)
  10. Females of childbearing potential (non childbearing is defined as greater than one year post-menopausal or surgically sterilized) must use acceptable contraceptive methods (abstinence, intrauterine device, oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 7 days prior to beginning treatment on this trial. Sexually active men must also use acceptable contraceptive methods for the duration of time on study.
  11. Patient should be 15 years of age or older

Exclusion Criteria:

  1. 1. Patients with brain metastases not stable for 2 months.
  2. Patients taking primidone, carbamazepine, phenobarbital or phenytoin anticonvulsants (Enzyme-Inducing Anti-Epileptic Drugs - EIAED). Patients changing from these anticonvulsants to others that are allowed must be off the drugs listed above for at least 1 week before start of treatment.
  3. Patients with > Grade 2 neuropathy
  4. Patients with uncontrolled high blood pressure (systolic BP > 140 for patients < 50 years old and >160 for patients > 50 and/or diastolic BP>90 for patients< 50 year old and >99 for patients over 50) unstable angina, symptomatic congestive heart failure, clinical history of myocardial infarction within the previous six months, or serious uncontrolled cardiac arrhythmia as determined by the principal investigator.
  5. Because of the concerns for the potential interaction of TPI 287 and medications taken by patients who are HIV positive or have AIDS related diseases, patients who are HIV positive are not eligible for entry into this study. Only patients with suspected HIV will be tested and if positive, will be ineligible.
  6. Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) are ineligible unless in complete remission and off of all therapy for that disease for a minimum of 3 years.
  7. Patients with: a. Active infection associated with fever lasting more than 24 hours requiring antibiotics b. Disease that will obscure toxicity or dangerously alter drug metabolism c. Serious intercurrent medical illness The Principal investigator or his designee will make the final decision regarding eligibility for enrollment.
  8. Female patients who are pregnant or breastfeeding
  9. Patients younger than 15 years of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01340729

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Cortice Biosciences, Inc.
Investigators
Study Chair: Agop Y. Bedikian, MD, BS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01340729     History of Changes
Other Study ID Numbers: 2010-0839
Study First Received: April 20, 2011
Last Updated: April 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
melanoma
TPI 287
tumor recurrence
tumor progression
novel taxane analog

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 17, 2014