Study of TPI 287 in Patients with Advanced Malignancies - Article Caverject; Edex Kit
Clinical Trial: Study of TPI 287 in Patients with Advanced Malignancies
This study is currently recruiting patients.
|Neoplasms || Drug: TPI 287 Injection ||Phase I |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: A Phase I, Open-Label, Dose Escalation, Multi-Center Study of TPI 287 in Patients with Advanced Malignancies
Secondary Outcomes: To determine the safety of TPI 287; To determine the antitumor activity of TPI 287; To determine the pharmacokinetic profile of TPI 287; To determine the pharmacodynamic profile of TPI 287
Expected Total Enrollment: 48
Study start: May 2005
Last follow-up: June 2005
The secondary objectives of the study are:
- To determine the safety of TPI 287
- To determine antitumor activity of TPI 287
- To determine the pharmacokinetic profile of TPI 287
- To determine the pharmacodynamic profile of TPI 287
- Histological or cytological evidence of malignancy
- Patients must have either: * advanced solid tumors that have recurred or progressed following standard therapy, or * Hodgkin''''s or non-Hodgkin''''s lymphoma that has recurred or progressed following standard therapy, have not had a previous bone marrow transplant, and are not eligible for a bone marrow transplant.
- Failed at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy.
- Ambulatory with ECOG 0 or 1, and a life expectancy of >3 months.
- Judged by the investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits.
- Have ability to read, understand and provide written informed consent for the initiation of any study related procedures or have a legal representative to perform this function.
- If female, must have a negative pregnancy test within 21 days of start of treatment.
- Agree to the use of an effective method of contraception during the study and for 90 days following the last dose of medication.
- Patients with prior radiation therapy for brain metastasis or primary brain tumors are acceptable.
- Prior radiation therapy or chemotherapy within 4 weeks (6 weeks for prior nitrosoureas or mitomycin)
- Another active medical condition(s) or organ disease(s) that may either compromise patient safety or interfere with the safety and/or outcome evaluation of the study drug. While this exclusion is not limited to the following abnormalities, if any of the following laboratory abnormalities are present, the patient should be excluded: * WBC < 3000/uL; * Absolute neutrophil count < 1500/uL; * Platelets < 100,000/uL; * Total bilirubin > 1.5 x upper limit of normal; * ALT or AST > 3 x upper limit of normal if no liver metastases or >5 upper limit of normal in the presence of liver metastases; * Serum creatinine > 1.5 x upper limit of normal; * INR >2.0.
- Patient has clinically significant cardiac co-morbidities or pulmonary impairment
- Patient or physician plans concomitant chemotherapy, radiation therapy, hormonal and/or biological treatment for cancer including immunotherapy while on study. Of note, therapy with LHRH for prostate cancer is acceptable.
- Patient has been treated with any investigational drug, investigational biologic, or investigational therapeutic device within 30 days of initiating study treatment.
- Tumor appears to involve a major artery or vein.
- Prior or concurrent significant CNS disease including stroke, except for primary or secondary malignancies.
- Less than 4 weeks since prior major surgery
- Known positive for HIV, Hepatitis B or C
- Concurrent chronic use of aspirin (325 mg/day or more)
- Concurrent or recent (within 1 month) use of thrombolytic agents, or full-dose anticoagulants (except to maintain patency of preexisting, permanent indwelling IV catheters) Of note, therapy with low-molecular weight heparin is acceptable as long as the INR<2.0.
- Uncontrolled hypertension
- Grade II-IV peripheral vascular disease within the past year
- Prior allergic reactions to compounds of similar chemical or biologic composition to TPI 287, paclitaxel or taxotere, Cremophor-EL-P, or other study agents
- Significant traumatic injury within the past 4 weeks
- Ongoing or active infection requiring parenteral antibiotics or with a fever >38.1°C within 3 days of the first scheduled day of dosing
- Other concurrent uncontrolled illness which may interfere with the ability of the patient to participate in the trial
- Patients who are inpatients
- Grade II-IV peripheral neuropathy
Location and Contact Information
District of Columbia
Georgetown University Medical Center/Lombardi Cancer Center, Washington, DC, District of Columbia, 20007-2113, United States; Recruiting
Cassandra R. Pusey 202-784-4086 firstname.lastname@example.org
John L Marshall, MD, Principal Investigator
New York Medical College, Valhalla, New York, 10595, United States; Recruiting
Paul Baskind 914-493-7508 email@example.com
Tauseef Ahmed, MD, Sub-Investigator
Gilad Gordon, MD, Study Director, Tapestry Pharmaceuticals, Inc.
Record last reviewed: June 2005
Last Updated: June 30, 2005
Record first received: June 9, 2005
ClinicalTrials.gov Identifier: NCT00113724
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05