The Nalitt Institute for Cancer and Blood-Related Diseases offers clinical trials for a wide range of cancers. These studies include unique Phase I and II trials developed at the Nalitt Institute, as well as Phase III and Phase IV trials, which are organized by academic groups and pharmaceutical companies. 

While standard treatment is always available, patients at the Nalitt Institute are also informed about the option of participating in clinical trials. Participation in clinical trials offers several advantages. Phase III trials compare the best available standard treatment to the most promising new regimens in a very carefully designed plan of treatment and monitoring. Phase I and II trials provide unique access to promising new treatments for patients who are in need of additional treatment after receiving one or more standard treatment regimens. Thus, patients, in concert with the Nalitt healthcare team, can make an informed decision regarding treatment.

The Nalitt Institute actively develops and conducts clinical trials in concert with other allied specialties at SIUH, and participates in National Cancer Institute-sponsored cooperative groups such as CALGB and NSABP. In addition, we are  a site for trials sponsored by major pharmaceutical companies.

Below is a list of the protocols presently active at the Nalitt Institute. For more information, contact the Nalitt Institute Information Line: at (718) 226-8888.

SITE

STAGE/HISTOLOGY

DESCRIPTION

BREAST

NSABP B-37

 

Randomized Clinical Trial of Adjuvant Chemotherapy for Radically Resected loco-regional relapse of Breast Cancer

Arm A

Observation (+ Radiation Therapy); ER+ and/or PgR+:  Hormonal treatment* HER-2+:  Trastuzumab (optional)

Arm B

Chemotherapy**(+Radiation Therapy)

ER+ and/or PGR+:  Hormonal treatment* HER-2+:  Trastuzumab (optional)

S0500

 

A Randomized Phase III Trial to Test the Strategy of Changing Therapy Vs. Maintaining Therapy for Metastatic Breast Cancer Patients Who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment

The purpose of this experimental study is to find out if the CellSearch blood test, which identifies tumor cells in the blood, can predict survival outcome in patients with metastatic breast cancer.  These tumor cells are called circulating tumor cells (CTCs).  The CellSearch blood test may allow doctors to tell if your current chemotherapy is not working before you show signs that your cancer is getting worse.  This is based upon a prior study that showed that most women with high numbers of CTCs had their breast cancer getting worse within 1-3 months. 

NSABP B-42

 

Clinical Trial to Determine the Efficacy of Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of An Aromatase Inhibitor (A1) or Tamoxifen Followed by and A1 in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Cancer

Stratification

  • Pathologic Nodal Status (negative, positive)
  • Tamoxifen as Adjuvant Therapy (yes, no)
  • Lowest Bone Mineral Density T score for LS spine, total hip, or femoral neck (>2.0, <-2.0 SD)

Group 1

Placebo taken orally once daily for 5 years

Group 2

Letrozole 2.5 mg taken orally once daily for 5 years

S0226

 

Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant First Line Therapy for Post Menopausal Women with Metastatic Breast Cancer

Phase III Randomized Trial Regustratuib/

Randomization

Arm 1:

Anastrozole

Progression or Symptomatic

Deterioration Crossover to Fulvestrant

Arm 2:

Anastrozole and Fulvestrant Progression or Symptomatic Deterioration

Off Protocol Treatment

SOFT (Suppression of Ovarian)

Premenopausal Women with Stage I-III, ER+ or PR+ breast cancer (adjuvant chemo is allowed)

Phase III Trial - 3 Arms

  1. Tamoxifen alone vs.
  2. OFS + Tamoxifen vs.

  3. OFS + Exemestane

S0307

 

 

 

 

Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer

Phase III - 3 Arms

Arm 1:

Zoledronic acid 4 mg IV q 4 weeks x 6 months then q 3 months x 2 ½ weeks

Arm 2:

Condronate 1600 mg PO q day x 3 years

Arm 3:

Ibandronate 50 mg PO q day x 3 years

Note:  Bisphosphonate therapy should be started as soon as possible after surgery (within 84 days).  Protocol registration and bisphosphonate treatment can begin prior to, simultaneously or after systemic therapy begins.

CALGB 40302

Endocrine Therapy with or Without Inhibition of EGF and HER2 Growth Factor Receptors:  A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant with or without Lapatinib (GW572016) for Postmenopausal, Women with Hormone Receptor Positive Advanced Breast Cancer

This is a double-blind study

Fulvestrant+Lapatinib

C1:

Day 1 - Fulvestrant 500 mg IM x 1:

Day 15 - Fulvestrant 250 mg IM x1

Day 1-28 - Lapatinib - 1500 mg PO QD

C2, and each cycle thereafter:

D1- Fulvestrant 250 mg IM x 1

Day 1-28-Lapatinib-1500 mg PO QD

Versus

Fulvestrant + Placebo

C1:

Day 1 - Fulvestrant 500 mg IM x 1:

Day 15 - Fulvestrant 250 mg IM x 1.

Day 1-28-Placebo-PO QD

C2 and each cycle thereafter:

D1-Fulvestrant 250 mg IM x1

Day 1-28-Placebo-PO QD

One Cycle=28 days

ECOG-

TAILORxPACCT-1

 

ER Positive and/or PR-Positive Breast Cancer HER2 neu-Negative Axillary Node-Negative-Candidate for Adjuvant Cytoxic Therapy in Addition to Hormonal Therapy

Stratify

  • Tumor size:  <2.0 cm vs.>2.1 cm
  • Post menopausal vs. pre-or peri-menopausal
  • Planned chemotherapy:  Taxane-containing (i.e. paclitaxel, docetaxel) vs. non-taxane-containing
  • Planned radiation therapy:  Whole breast, no boost planned vs. whole breast, boost planned vs. partial breast irradiation planned vs. no planned radiation therapy (for patients who had a mastectomy)

COLORECTAL

E5204

Stage II and III Rectal Cancer Receiving Pre-operative Chemoradiation

Arm A

Oxaliplatin/Leucovorin/5FU

Arm B

Bevacizumab/Oxaliplatin/Leucovorin/5-FU

NSABP R-04

Stage II and III Rectal Carcinoma

Group 1

5-FU

225 mg/m²/day by continuous infusion for 5 days per week on days of planned RT + Pelvic RT

Group 2

5-FU

225 mg/m²/day by continuous infusion for 5 days per week on days of planned RT + Pelvic RT

 + Oxaliplatin 50 mg/m² IV weekly x 5 concurrently with RT + Pelvic RT

Group 3

Capecitabine 825 mg/m² po BID 5 days per week throughout RT _ Pelvic RT

Group 4

Capecitabine 825 mg/m² po BID 5 days per week throughout RT _ Oxaliplatin 50 mg/m² IV weekly x 5 concurrently with RT + Pelvic RT Surgery

N0147

A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-FU/Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer

Phase III Trial

Arm A  (FOLFOX):

  • Oxaliplatin 85 mg/m² IV Day 1
  • Leucovorin 400 mg/m² IV Day 1
  • 5-FU 400mg/m² IVP Day 1
  • 5-FU 2400 mg/m²IV CIV lover 46-48 hours Day 1
  • Give 12 14-day cycles

Arm D (FOLFOX + Cetuximab)

Cycle 1:

·        Cetuximab 400 mg/m² IV Day 1

·        FOLFOX as above

·        Cetuximab 250 mg/m² IV Day 8

·        14-Day cycle

Cycles - 12:

·        Cetuxiimab 250 mg/m² IV Days 1 and 8

·        FOLFOX as above

·        14-day cycles

  CALGB 80405

Phase III Untreated Metastatic Adenocarcinoma of the Colon or Rectum

Phase III Trial

1 Cycle = 8 weeks

Arm A:

Bevacizumab 5 mg/kg IV every 2 weeks followed by FOLFOX or FOLFIRI every 2 weeks

Arm B:

Cetuximab 400 mg/m² IV on Day 1 of Cycle 1 only, then 250 mg/m² IV weekly followed by FOLFOX or FOLFIRI every 2 weeks

Arm C:

Cetuximab 400 mg/m² IV on Day 1 of Cycle 1 only, then 250 mg/m² IV followed by Bevacizumab 5 mg/kg IV every 2 weeks, followed by FOLFOX or FOLFIRI

E5202

A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers

Phase III Trial

Arm A

  • Oxaliplatin 85 mg/m² IV over 2 hrs
  • Leucovorin 400 mg/m² IV over 2 hrs
  • 5-FU 400 mg/m² IV bolus injection, immediately following leucovorin
  • 5-FU 2.4 gm/m² continuous infusion over 46 hours immediately following bolus 5-FU
  • Cycle=2 treatment days q 2 wks
  • Repeat for 12 (2-week) cycles

Arm B

  • *Bevacizumab 5 mg/kg IV over 90 minutes
  • Oxaliplatin 85 mg/m² IV over 2 hrs.
  • Leucovorin 400 mg/m² IV over 2 hrs
  • 5-FU 400 mg/m² IV bolus injection, immediately following leucovorin
  • 5-FU 2.4 gm/m² continuous infusion over 46 hrs immediately following bolus 5-FU
  • Cycle=2 treatment days q 2 wks
  • Repeat for 12 (2-week) cycles

*Continue bevacizumab (alone) for 12 additional (2-week) cycles following completion of 1st 12 cycles of treatment

Arm C

OBSERVATION

GASTRIC/GASTRO ESOPHAGEAL

CALGB 80101

 

Trial of Adjuvant Chemo-radiation after Resection of Gastric and Gastro-esophageal Adenocarcinoma

Phase III Trial

Arm A:

Chemotherapy (C1, C3, C4:  Each cycle = 28 days Leucovorin

Arm B:

Chemotherapy (For 1 cycle only (one cycle=28 days)

Epirubin (Arm A & B R/w continuous infusion 5-FU

LEUKEMIA/LYMPHOMA

S0106

Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg®) Induction Therapy Versus Standard Induction with Daunomycin and Cytosine Arabinoide followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy with Gemituzumab Ozogamicin (Mylotarg®) or No Additional Therapy for Patients Under Age 56 with Previously Untreated DeNovo Acute Myeloid Leukemia (AML)

A Phase III Study

  • Induction (Randomization)

Arm 1:  Daunomycin

                Gemtuzumab

                 Ara-C

  • Consolidation

  • (Additional eligibility)

  • HiDaC (3 cycles)

  • Post Consolidation

  • (Additional eligibility and randomization

    1. Gemtuzumab x 3 cycles

    2. No Therapy

  ADVANCED OVARIAN-PRIMARY PERIOTONEAL CANCER

GOG-0218

Phase III Trial of Carboplatin and Paclitaxel plus Placebo versus Carboplatin and Paclitaxel plus Concurrent Bevacizumab followed by placebo, versus carboplain and Paclitaxel plus Concurrent and Extended Bevacizumab, in-Women with Newly Diagnosed, Previously Untreated, Stage III (Suboptimal) and all Stage IV, Epithelial Ovarian or Primary Perioteneal Cancer 1

Arm 1

(Standard Chemotherapy)

Arm II

(Concurrent Bevacizumab)

Arm III

(Extended Bevacizumab)

  PROSTATE CANCER

CALGB 90401

Randomized, Double-Blind, Placebo-Controlled, Phase III Trial Comparing Docetaxel and Prenisone with and without Bevacizumab (IND#7921, NSC#704865) in Men and Hormone Refractory Prostate Cancer

Phase III Trial

1 Cycle = 21 Days

Arm A:

Docetaxel + placebo q 21 days plus prednisone 5 mg po

Docetaxel + bevacizumab q 21 days plus prednisone 5 mg po bid

RENAL CELL CARCINOMA

E2805

Randomized, Double-Blind Phase III Trial of Adjuvant Sunitinib vs. Sorafenib vs. Placebo in Patients with Resected Renal Cell Carcinoma

Phase III Trial

Pre-surgical Criteria:

  • Patients must have primary-intact renal cell carcinoma, eligible for nephrectomy with curative intent.

  • Tumors >4 cm and/or macroscopic fully resectiable nodes and/or surgically resectable inferior vena caval thrombus by radiologic criteria to be clinically > pT1bNany (respectable) MO disease

  • Multifocal ipsilateral rental cell carcinoma is allowed provided fully respectable and does not exceed inclusion criteria.

Arm A (Sunitinib)²

Arm B (Sorafenib)²

Arm C (Placebo)²

BRAIN TUMORS

SIUH GBM Protocol

A Phase II Study of Radiation with Concurrent and then Sequential Temozolomide (TMZ) in patients with New Diagnosed High Grade Malignant Glioma (MG) who have undergone surgery with Carmustine (BCNU) Wafer Insertion

The goal of this study is to improve on the effectiveness of treatment modality for the brain tumors GBM and AA. 

TREATMENT PLAN

Schematic Representation of the Treatment Plan

  • Treatment

  • Day 0:  Surgery + Gliadel

C1 (6 Weeks)

  • RT 5d/week +TMZ 75 mg/m2 daily

  • Completion of RT/TMZ

C2,3,4...

  • Maintenance

  • TMZ 200 mg/m2-D1-5Q28d

RETURN TO: Nalitt Home          RETURN TO: SIUH Home