NCT00939172

Brief Summary

The goal of this clinical research study is to find the highest tolerable dose of TTP607 that can be given to patients with a solid tumor or lymphoma. The safety of TTP607 will also be studied. Researchers will also do pharmacokinetic (PK) testing of TTP607. PK testing measures the amount of a drug in the body at different time points.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
Last Updated

July 31, 2012

Status Verified

July 1, 2012

First QC Date

July 10, 2009

Last Update Submit

July 27, 2012

Conditions

Advanced CancersLymphoma

Keywords

Advanced Refractory Solid MalignanciesSolid tumorLymphomaTTP607

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose

    End of each 15 day cycle

Study Arms (1)

TTP607

EXPERIMENTAL
Drug: TTP607

Interventions

TTP607DRUG

3.3 mg/m\^2 given by central venous catheter over 1-4 hours, each day for 5 days in a row, for a 15 day cycle.

TTP607

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with pathologically confirmed advanced malignancy that is metastatic or unresectable and which is refractory to standard therapy or for which there is no standard therapy.
  • Measurable disease at baseline.
  • At least four weeks since the last dose of prior chemotherapy, radiation therapy, or investigational agents, six weeks if the last regimen included BCNU or mitomycin C, six weeks if the agent was an antibody, four weeks if a chimeric antibody. For targeted therapies such as Gleevec®, Tarceva®, Nexavar®, Iressa®, or Sutent® at least five half-lives need to have elapsed since the last dose. Patients must be recovered from the adverse effects of prior therapy at the time of enrollment.
  • Age \>/=18 years, male or female patients.
  • Women of child-bearing potential or men whose sexual partners are women of child-bearing potential must agree to use two methods of adequate contraception (i.e., hormonal and barrier method of birth control) prior to study entry, for the duration of the study, and for 30 days after the last dose of study medication.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
  • Patients must have normal organ and marrow function as defined: leukocytes \>/= 3,000/mcL; absolute neutrophil count \>/=1,500/mcL; platelets \>/= 100,000/mcL; total bilirubin \</= 2.0 mg/dL; AST(SGOT)/ALT(SGPT) \</= 2.5 x upper limit of normal; and creatinine \</= 2.0 mg/dL
  • Patients must have an existing patent and viable central venous catheter, or have such a line inserted within 28 days prior to initiation of study drug.
  • Patients must be able to understand and willing to sign a written informed consent document and have the capacity to follow study instructions.

You may not qualify if:

  • Uncontrolled concurrent illness, including but not limited to: ongoing or active infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, life-threatening cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements and/or obscure study results. Patients with a history of myocardial infarction in the last three months are also excluded from the trial.
  • Patients with known brain metastases that are symptomatic
  • Patients with leukemias or myelodysplastic syndrome (MDS).
  • Patients who have undergone bone marrow or stem cell transplantation within the last 5 years.
  • A requirement, as judged by the Principal Investigator, for primary prophylaxis with colony stimulating factors based on an expectation by the investigator of a risk of febrile neutropenia of 20% or greater or clinical factors that predispose the patient to increased complications from prolonged neutropenia as discussed in the latest American Society of Clinical Oncology (ASCO) recommendations for the use of white blood cell growth factor guidelines.
  • Nursing or pregnant women.
  • Documented HIV, HBV or HCV infection.
  • Patients with hypersensitivity to compounds of similar chemical or biologic composition to TTP607 or constituents of the intravenous (i.v.) formulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jennifer J. Wheler, MD

    UT MD Anderson Cancer Center

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 14, 2009

Study Start

March 1, 2010

Last Updated

July 31, 2012

Record last verified: 2012-07