NCT00090727

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

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

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

Study Start

First participant enrolled

August 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 6, 2004

Completed
Last Updated

November 2, 2006

Status Verified

April 1, 2005

First QC Date

September 2, 2004

Last Update Submit

October 31, 2006

Conditions

Solid MalignanciesNon-Hodgkin's Lymphoma

Keywords

diffusefollicularchronic lymphocytic leukemiacolorectal cancerpancreatic canceracute myelogenous leukemiahead and neck cancerbreast cancerprostate cancerovarian cancerbladder cancerhypoxiarefractorymetastatic

Interventions

AQ4NDRUG

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Weiler Hospital of Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Cancer Therapy & Research Center / Institute for Drug Development

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-CellColorectal NeoplasmsPancreatic NeoplasmsLeukemia, Myeloid, AcuteHead and Neck NeoplasmsBreast NeoplasmsProstatic NeoplasmsOvarian NeoplasmsUrinary Bladder NeoplasmsHypoxiaNeoplasm Metastasis

Interventions

AQ4N

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesLeukemia, MyeloidBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Neoplasms, FemaleGonadal DisordersUrologic NeoplasmsUrinary Bladder DiseasesUrologic DiseasesSigns and Symptoms, RespiratorySigns and SymptomsNeoplastic Processes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 2, 2004

First Posted

September 6, 2004

Study Start

August 1, 2004

Last Updated

November 2, 2006

Record last verified: 2005-04

Locations

US(2)