Clinical trial NCT00088101: STA-5312 Administered on Alternate Weekdays Every Two Weeks to Patients With Hematologic Malignancies and Patients With Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hematological Malignancies
Leukemia
Lymphoma
Metastatic or Unresectable Solid Tumors
Keywords: Hematological Malignancies
Leukemia
Lymphoma
Metastatic
Unresectable solid tumors
Lead sponsor: Synta Pharmaceuticals Corp.
Sponsor class: INDUSTRY
First posted: 2004-07-21
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pamona
country: United States
facility: Wilshire Oncology Medical Group
state: California
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Boston
country: United States
facility: Tufts New England Medical Center
state: Massachusetts
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Charlotte
country: United States
facility: Carolinas HealthCare System
state: North Carolina
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Nashville
country: United States
facility: The Sarah Cannon Cancer Center
state: Tennessee
Study officials:
References: