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A Phase 1/2, Open Label, Dose Escalation Study of AQ4N for Safety, Tolerability, Pharmacokinetics and Activity in Patients With Lymphoid Neoplasms


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia

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Trial Information

A Phase 1/2, Open Label, Dose Escalation Study of AQ4N for Safety, Tolerability, Pharmacokinetics and Activity in Patients With Lymphoid Neoplasms


All patients in this study will receive AQ4N one time every three weeks for a maximum of 24
weeks. Each patient will receive the same dose for the entire time he/she is on the study.
However, some patients may receive a different dose than other patients depending upon when
they enter the study.

When the study begins, the first three patients will receive a dose of 400 mg/m2. After
they have all been observed for 2 weeks, and if side effects do not occur or are tolerable,
another three patients will enter the study at a higher dose. The increase in dose may
continue with new patient groups until side effects reach a point where they are not
tolerated. At that point no higher doses will be tried and more patients will be allowed to
enter at one or two lower doses where the side effects were tolerated.

Up to 55 patients will be entered in this study at up to 8 research centers in the United
States. Study duration will be approximately 27 weeks or 8 treatment cycles (One treatment
cycle lasts 3 weeks and begins on Day 1 with an infusion of AQ4N.)

The following procedures will be completed at the time of screening and throughout the
study: review of medical and cancer history, previous cancer treatments, and current
medications, a complete physical exam, and blood (4 to 6 teaspoons) and urine tests. Two
additional tests to evaluate the heart, an electrocardiogram (ECG) and a multiple gated
acquisition assessment (MUGA) will be performed. Cancer progression will be monitored by a
computed tomography scan (CT scan) and a bone marrow biopsy.


Inclusion Criteria:



- Diagnosis of Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, or Small
Lymphocytic Leukemia

- Tumor specimen available for evaluation (please provide 10 unstained slides)

- Relapse after receiving primary treatment and at least one salvage therapy

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

- Laboratory test measurements

- Females of childbearing potential must have a negative pregnancy test result within 3
days prior to the first dose and must agree to use an effective contraceptive method
during the course of the study and for 6 months following the last dose of study
drug.

- Older than 18 years of age

- Available for periodic blood sampling

Exclusion Criteria:

- Certain cardiac problems

- Previous donor stem cell transplant

- Known HIV, Hepatitis B, Hepatitis C infection

- Previous chemotherapy, radiation or other investigational drug treatments within 4
weeks of first planned dose of study drug

- Major surgery within four weeks of first planned dose of study drug

- Any active viral, bacterial, or fungal infection within four weeks of first planned
dose of study drug

- Pregnant or breastfeeding

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response rate

Authority:

United States: Food and Drug Administration

Study ID:

021-002

NCT ID:

NCT00109356

Start Date:

March 2005

Completion Date:

March 2007

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Leukemia
  • Non-Hodgkin's Lymphoma
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Weill Medical College of Cornell University/ New York Presbyterian HospitalNew York, New York  10021