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Chemotherapy for Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

Primary Purpose

Solid Malignancies, Non-Hodgkin's Lymphoma

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AQ4N
Sponsored by
Novacea
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Malignancies focused on measuring diffuse, follicular, chronic lymphocytic leukemia, colorectal cancer, pancreatic cancer, acute myelogenous leukemia, head and neck cancer, breast cancer, prostate cancer, ovarian cancer, bladder cancer, hypoxia, refractory, metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Advanced solid malignancy or non-Hodgkin's lymphoma that is refractory to treatment or has recurred Age > 18 years Adequate hematologic (blood), kidney and liver function Negative pregnancy test (females of childbearing potential only) Willingness to use effective contraception by both males and females throughout the treatment period and for at least 2 months following treatment. Exclusion Criteria: Any chemotherapy or radiation within the past 4 weeks Symptomatic or uncontrolled brain metastases (patients with history of brain metastases who have had repeat brain scans within the past 30 days that demonstrate no evidence of tumor progression or brain swelling and who do not require corticosteriod treatment may be eligible) Significant cardiovascular illness including, but not limited to, the following: active infection, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, heart attack within the past six months, or uncontrolled, irregular heart beat Inadequate cardiac function Prior investigational therapy within the past 28 days Pregnant or breast feeding women

Sites / Locations

  • Weiler Hospital of Albert Einstein College of Medicine
  • Cancer Therapy & Research Center / Institute for Drug Development

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 2, 2004
Last Updated
October 31, 2006
Sponsor
Novacea
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1. Study Identification

Unique Protocol Identification Number
NCT00090727
Brief Title
Chemotherapy for Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
Official Title
A Phase 1, Open-Label, Dose-Escalation Study of AQ4N Administered Intravenously in Patients With Advanced Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
April 2005
Overall Recruitment Status
Unknown status
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novacea

4. Oversight

5. Study Description

Brief Summary
The purposes of this study are to determine: the largest dose of AQ4N that can be safely given once a week for three weeks out of a 4 week cycle the side effects of AQ4N when given on the above schedule how much AQ4N is in the blood and urine at specific times after administration and how the body get rids of AQ4N if AQ4N helps treat cancer
Detailed Description
This study is for people who have advanced cancer for which standard chemotherapy did not work or for which there are no reliably, effective treatments. AQ4N is an experimental chemotherapy that is thought to target tumor areas with low oxygen content and low blood supply; tumor areas that are usually the most resistant to standard chemotherapy and radiation treatment. AQ4N may be beneficial in cancer treatment by interfering with a protein that is required for cells to grow and divide, causing tumors to die or to delay their growth. All patients in this study will receive AQ4N. The dose will be increased for each new patient or group of patients until the maximum tolerated dose is reached.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Malignancies, Non-Hodgkin's Lymphoma
Keywords
diffuse, follicular, chronic lymphocytic leukemia, colorectal cancer, pancreatic cancer, acute myelogenous leukemia, head and neck cancer, breast cancer, prostate cancer, ovarian cancer, bladder cancer, hypoxia, refractory, metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
AQ4N

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Advanced solid malignancy or non-Hodgkin's lymphoma that is refractory to treatment or has recurred Age > 18 years Adequate hematologic (blood), kidney and liver function Negative pregnancy test (females of childbearing potential only) Willingness to use effective contraception by both males and females throughout the treatment period and for at least 2 months following treatment. Exclusion Criteria: Any chemotherapy or radiation within the past 4 weeks Symptomatic or uncontrolled brain metastases (patients with history of brain metastases who have had repeat brain scans within the past 30 days that demonstrate no evidence of tumor progression or brain swelling and who do not require corticosteriod treatment may be eligible) Significant cardiovascular illness including, but not limited to, the following: active infection, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, heart attack within the past six months, or uncontrolled, irregular heart beat Inadequate cardiac function Prior investigational therapy within the past 28 days Pregnant or breast feeding women
Facility Information:
Facility Name
Weiler Hospital of Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Cancer Therapy & Research Center / Institute for Drug Development
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Chemotherapy for Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

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