Clinical Trials

Clinical research plays a vital role in the war on cancer.  Through research we discover new and better ways to fight this disease, improve the quality of life for patients, and ultimately one day, to prevent cancer.  Research studies, also called clinical trials or protocols, help develop better treatments to improve survival, understand how cancer grows and manage side effects of treatment to improve quality of life. Pearlman offers clinical trials sponsored by the National Cancer Institute as well as pharmaceutical companies.

Exciting Times

Two of the most exciting advances in cancer care in recent times are immunotherapy and precision medicine. Both of these approaches represent a new way of thinking about fighting cancer that is distinctly different than standard chemotherapy. We offer clinical trials that use both of these lines of attack for advanced cancers that are difficult to treat.

Immunotherapy

Immunotherapy is a broad term that refers to using the power of the immune system to fight a disease. Several types of immunotherapies have been used to treat cancer for over 20 years. Most recently, the use of checkpoint inhibitors has generated a lot of interest and excitement in the world of cancer. These agents take the brakes off of the immune system and allow it to recognize and destroy cancer cells that were previously cloaked from detection. Scientists have discovered that some cancers hijack a biological process that protects normal tissues from over-reaction by our immune system, and use it to hide from immune cells that would otherwise seek and destroy. These checkpoint inhibitors have been shown to be very effective in some cases of advanced melanoma, lung cancer, kidney cancer, and bladder cancer. We're only just beginning to understand how to best use these therapies against some very difficult to treat cancers. EA5142, SWOG 1400I, SWOG 1404, SWOG 1418, and JAVELIN Lung 100 are five examples of clinical trials at Pearlman that use immunotherapies. 

Precision Medicine

For many years, researchers have been interested in refining the strategy for treating chronic or life-threatening diseases using more precise means of targeting the driver of the illness. In cancer, we’re examining the molecular environment and genetic code of tumors to identify abnormalities that can be eliminated or altered by a drug. Pearlman Cancer Center has opened several trials through the National Cancer Institute’s Precision Medicine Initiative that will offer patients with advanced cancers an opportunity to benefit from this innovative strategy.

The Lung-MAP Study (SWOG 1400) was the first of these trials, and it consists of several sub-studies within the larger umbrella trial. New sub-studies will be added as new potential targets are identified for exploration in squamous cell lung cancer. ALCHEMIST and the Exceptional Responders Initiative are also open. ALCHEMIST examines the usefulness of drugs that target two specific abnormalities in early stage lung cancer that has been surgically removed. Normally these drugs (erlotinib and crizotinib) are reserved for patients with more advanced cancer. But we often find that drugs that are useful in more advanced disease have a role in earlier stage disease, and result in improved survival and lower rates of recurrence. ALCHEMIST has opened a third substudy that uses an immunotherapy agent, also normally reserved for patients with more advanced cancer. The Exceptional Responders Initiative is unique in that it looks back at patients who had unexpected and durable responses to treatment – what was unique about their cancers that allowed them to have such an extraordinary response? Can we exploit that finding to benefit future patients? NCI-MATCH is a trial that gives patients with advanced disease an opportunity to be treated with novel agents that target specific mutations or markers identified in their tumors. It's important that these patients have tried the approved standard therapies to treat their disease before enrolling on a trial using an investigational agent. 

This is an exciting time in cancer research as we discover how to use the unique biology of the patient’s tumor to fight these difficult cancers.

Clinical Trials: Protocols Available by Disease Site

Breast

Adjuvant

A011502
A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2 Negative Breast Cancer:  The ABC Trial

EA1131
A Randomized Phase III Post-operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy

NRG-BR003
A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or Without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

NSABP B-55
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA 1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer who have Completed Definitive Local Treatment and Neoadjuvant or adjuvant Chemotherapy

SWOG 1418
A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with > 1 cm Residual Invasive Cancer or Positive Lymph Nodes (>pN1mic) After Neoadjuvant Chemotherapy 


Metastatic

SWOG 1416
Phase II Randomized Placebo-Controlled Trial of Cisplatin with or without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer

 

Lung

Adjuvant

A151216
(ALCHEMIST) Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial. A screening trial for A081105 and E4512.

E4512
(An ALCHEMIST sub-study) A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

A081105
(An ALCHEMIST sub-study) Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Lung Cancer (NSCLC)

EA5142
(An ALCHEMIST sub-study) Adjuvant Nivolumab in Resected Lung Cancers (ANVIL) - A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers

Metastatic

SWOG 1400
A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer
 
SWOG 1403
A Randomized Phase II/III Trial of Afatinib Plus Cetuximab Versus Afatinib Alone in Treatment-Naive Patients with Advanced, EGFR Mutation Positive Non-Small Cell Lung Cancer

Melanoma

SWOG 1404
A Phase III Randomized Trial Comparing Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Melanoma

Solid Tumors

Metastatic

SWOG EAY 131 - MATCH (Molecular Analysis for Therapy Choice)
Study investigates whether tumors with mutations, amplifications or translocations in one of the genetic pathways of interest are likely to derive benefit from drugs that target that specific pathway.  Designed for patients with progressive disease or for whom no standard therapy exists.


The following disease sites have no studies available at this time:
 Colon, Gallbladder, Genitourinary, GIST, Head and Neck, Kidney, Leukemia, Lymphoma, Myeloma, and Pancreas.