STA-5312 Administered on Alternate Weekdays Every Two Weeks to Patients With Hematologic Malignancies and Patients With Solid Tumors

Lymphoma Clinical Trial

Official title:

Phase I Trial of STA-5312 Administered on Alternate Weekdays Every Two Weeks to Patients With Hematological Malignancies and Patients With Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00088101
• Other study ID #: 5312-01
• Status: Completed
• Phase: Phase 1
• First received: July 20, 2004
• Last updated: December 3, 2008
• Start date: February 2004
• Est. completion date: December 2004

Study information

• Verified date: December 2008
• Source: Synta Pharmaceuticals Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety, toxicity and patient tolerance of STA-5312 administered intravenously to patients with relapsed or refractory hematological malignancies and patients with solid tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female patients 18 years or older with one of the following malignancies:

• Histologically or cytologically confirmed hematological malignancy (other than Acute Myeloid Leukemia and Myelodysplastic Syndrome) and if treatment is medically indicated, or,

• Histologically-confirmed non-hematological malignancy that is metastatic or unresectable and for which no standard therapy is available.

• Patients with CLL, PLL, CML, CTCL, ATL, and Non-Hodgkin's Lymphoma may be entered if they are refractory to or have relapsed following conventional chemotherapy regimens such as alkylating agents (e.g. chlorambucil and cyclophosphamide), anthracycline combinations [e.g. CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone)], and/or purine analogues (e.g. fludarabine monophosphate and 2-CDA) and are not currently being considered for re-treatment with conventional regimens

• Patients with CLL and other leukemic malignancies will be staged according to the modified Rai staging criteria [low-risk, intermediate-risk and high risk]. All patients in the high-risk group (Stage III and IV) are eligible. Intermediate risk patients (Stage I and II) with one or more criteria of active disease (such as progressive lymphocytosis, lymphadenopathy, and splenomegaly, weight loss > 10% within 6 months, extreme fatigue, fever and/or night sweats without evidence of infection, etc.) are also eligible

• ECOG Performance Status of 0-2

• Life expectancy of greater than 12 weeks.

• Patients must have acceptable organ and marrow function at screening and pre-dose visits as defined below unless approved medically by the clinical investigator.

• Absolute neutrophils count greater than 1,000 cells/ul for patients with hematologic malignancies and =1,500 cells/ul for patients with solid tumors

• Platelets greater than 100,000/ul

• Hgb greater than 8.5 g/dL

• Total bilirubin must be <1.5 mg/dL or < 2X upper limit of normal

• AST (SGOT) < 2.5 times the upper limit of normal

• ALT (SGPT) < 2.5 times the upper limit of normal

• Adequate renal function (serum creatinine < 2.0 mg/dL or a calculated creatinine clearance greater than 50 mL/min)

• Electrocardiogram without evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator.

• NCI grade 0-1 left ventricular ejection fraction within 30 days of dosing.

• The effects of STA-5312 on the developing human fetus are unknown. Therefore, women of childbearing potential (defined as women under 50 years of age or history of amenorrhea for < 12 months prior to study entry) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform the treating physician immediately.

• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Women who are pregnant or lactating.

• Patients who have had chemotherapy, radiotherapy (except palliative radiation delivered to < 20% of bone marrow), immunotherapy, or corticosteroids ( > 10 mg/day of prednisone or equivalent) within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

• The use of nitrosoureas or mitomycin C within 6 weeks prior to study entry.

• Patients with prior peripheral blood stem cell rescue or bone marrow transplantation.

• History of primary brain tumors or active brain metastases. (Patients with previously treated brain metastases who are not receiving corticosteroids or anticonvulsants may be considered for enrollment)

• History of stroke or other significant neurologic limitations within 6 months prior to study enrollment

• Use of any investigational agents within 4 weeks of study enrollment.

• History of severe allergic reactions to excipients (e.g. Tween 80) or had hypersensitivity reactions to other chemotherapeutic agents similar in structure to STA-5312.

• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, as determined by the investigator.

• History of active CNS-lymphoma, AIDS-related lymphoma, or any uncontrolled severe medical illness or infection.

• Grade 2 or higher sensory or motor neuropathy at screening.

• Major surgery (excluding that for diagnosis) within 4 weeks of enrollment.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematological Malignancies
• Leukemia
• Lymphoma
• Metastatic or Unresectable Solid Tumors
• Neoplasms

Intervention

Drug:
• STA-5312

Locations

Country	Name	City	State
United States	Tufts New England Medical Center	Boston	Massachusetts
United States	Carolinas HealthCare System	Charlotte	North Carolina
United States	University of Chicago	Chicago	Illinois
United States	Baptist Cancer Institute	Jacksonville	Florida
United States	The West Clinic	Memphis	Tennessee
United States	The Sarah Cannon Cancer Center	Nashville	Tennessee
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Wilshire Oncology Medical Group	Pamona	California

Sponsors (1)

Lead Sponsor	Collaborator
Synta Pharmaceuticals Corp.

Country where clinical trial is conducted

United States,