Know Cancer

or
forgot password

Randomized Phase II Trial Of Sequential ATRA Then IL-2 For Modulation Of Dendritic Cells And Treatment Of Metastatic Renal Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Kidney Cancer

Thank you

Trial Information

Randomized Phase II Trial Of Sequential ATRA Then IL-2 For Modulation Of Dendritic Cells And Treatment Of Metastatic Renal Cancer


OBJECTIVES:

Primary

- Determine the ratio of dendritic cells (DC) to circulating immature cells (ImC) before
and after treatment with 3 different doses of tretinoin in patients with stage IV renal
cell cancer.

- Assess in vitro immune response assays to tetanus toxoid and influenza virus peptide
before and after treatment with tretinoin and interleukin-2 in these patients.

Secondary

- Determine the frequency of treatment-related side effects in these patients.

- Determine clinical objective response and progression-free survival of patients treated
with this regimen.

- Correlate DC:ImC ratio with clinical objective response in patients treated with this
regimen.

- Correlate the extent of change of the DC:ImC ratio with tretinoin dose and tretinoin
blood levels in these patients.

OUTLINE: This is a randomized, open-label study. Specimens are stratified according to
patient prognostic factors, tumor bulk, and extent of dendritic cell to circulating immature
cell ratio derangement. Patients are randomized to 1 of 3 tretinoin doses.

Patients are followed for up to 2 years.

PROJECTED ACCRUAL: A total of 27-36 patients (9-12 per treatment arm) will be accrued for
this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed renal cell cancer

- Stage IV disease

- Histology with clear cell component

- Metastatic OR incompletely resected disease

- Non-measurable disease allowed

- Underwent complete or partial nephrectomy more than 90 days ago

- No unresected primary cancer

- No more than 2 of the following adverse factors:

- Hemoglobin < 10.0 g/dL

- Corrected calcium > upper limit of normal (ULN)

- Lactic dehydrogenase > 1.5 times ULN

- Eastern Cooperative Oncology Group (ECOG) performance status 2

- Brain metastasis allowed provided more than 90 days of clinical and radiologic
stability after the end of its active treatment

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- See Disease Characteristics

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- See Disease Characteristics

Hepatic

- See Disease Characteristics

- Serum glutamic oxaloacetic transaminase (SGOT) < 3 times normal

- Bilirubin < 2 times normal

Renal

- See Disease Characteristics

- Creatinine clearance > 40 mL/min

Cardiovascular

- None of the following cardiovascular conditions within the past year:

- Uncontrolled hypertension

- Myocardial infarction

- Unstable angina

- New York Heart Association class II-IV congestive heart failure

- Serious cardiac arrhythmia requiring medication

- Class II-IV peripheral vascular disease within the past year

- Other clinically significant cardiovascular disease

Immunologic

- No history of immunodeficiency disease

- No HIV infection

- No ongoing serious infection

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use two methods of effective contraception during and for 1
month (for women) or 6 months (for men) after study treatment

- Other prior malignancy allowed provided there is no evidence of active disease

- No other medical contraindication to tretinoin or interleukin-2

- No serious non-healing wound, ulcer, or bone fracture

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 60 days since prior immunotherapy

Chemotherapy

- At least 60 days since prior cytotoxic chemotherapy

Endocrine therapy

- See Radiotherapy

- No prior corticosteroids at > physiologic replacement doses for > 3 days within the
past 90 days

- Concurrent tamoxifen, toremifene, megestrol, or gonadotropin-releasing hormone
agonists allowed

- Concurrent inhaled steroids allowed

Radiotherapy

- More than 7 days since prior external-beam radiotherapy

- No steroid requirement during radiotherapy

Surgery

- See Disease Characteristics

- At least 30 days since other prior debulking surgery

Other

- Prior adjuvant therapy for resected, synchronous stage IV disease allowed

- Prior adjuvant therapy allowed

- Study therapy is not to be used as adjuvant therapy for completely resected late
(> 1 year until identification) solitary site of disease metastasis or
non-metastatic disease

- No prior participation in this clinical study

- At least 60 days since other prior anticancer drugs

- Concurrent seizure medication allowed

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Ratio of Dendritic Cells (DC) to Circulating Immature Cells (ImC) Before and After Treatment

Outcome Description:

Determine the ratio of dendritic cells (DC) to circulating immature cells (ImC) before and after treatment with 3 different doses of tretinoin in patients with stage IV renal cell cancer.

Outcome Time Frame:

1 year, 3 months

Safety Issue:

No

Principal Investigator

Mayer Fishman, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

MCC-13920

NCT ID:

NCT00100906

Start Date:

August 2004

Completion Date:

September 2013

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • clear cell renal cell carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612