ALT803 for Sarcoma

Phase-Based Estimates
1
Effectiveness
1
Safety
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland, OH
Sarcoma+24 More
ALT803 - Biological
Eligibility
18+
All Sexes
Eligible conditions
Sarcoma

Study Summary

This study is evaluating whether a new treatment for cancer may be effective.

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Eligible Conditions

  • Sarcoma
  • Leukemia, Myeloid
  • Lymphoma
  • Rhabdomyosarcoma
  • Syndrome
  • Sarcoma, Ewing
  • Multiple Myeloma
  • Leukemia
  • Myelodysplastic Syndromes
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Lymphocytic, Acute, L1
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Soft Tissue Sarcoma (STS)
  • Ewing's Sarcoma
  • Acute Myeloid Leukemia (AML)
  • Myelodysplastic Syndromes (MDS)
  • Acute Lymphoblastic Leukemia (ALL)
  • Adenocarcinoma of Rectum
  • Myeloproliferative Syndromes
  • Plasma Cell Myeloma
  • Chronic Lymphocytic Leukemia (CLL)
  • Non-Hodgkin's Lymphoma (NHL)
  • Leukemia Chronic Myelogenous Leukemia (CML)
  • Colon Carcinoma
  • Lymphoma, Hodgkins
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether ALT803 will improve 2 primary outcomes and 12 secondary outcomes in patients with Sarcoma. Measurement will happen over the course of Up to 28 days.

Month 12
Average duration of Overall Survival
Average duration of relapse free survival
Average duration of response
Number of patients with hematological response
Patients response for Waldenstrom's macroglobulinemia (WM)
Patients response for chronic myeloid leukemia (CML)
Patients response for cutaneous lymphomas
Patients response for metastatic colon/rectal carcinoma and soft tissue sarcomas
Patients response for multiple myeloma
Patients response for radiographically measurable lesions
Patients with malignant lymphoma response
Up to 28 days
MTD of ex vivo expanded non-HLA matched donor NK cells in combination with ALT-803
Day 28
Number of participants without Graft Versus Host Disease (GVHD)
in vivo Natural Killer (NK) levels

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

No Cytokine Arm
Cytokine Arm

This trial requires 14 total participants across 2 different treatment groups

This trial involves 2 different treatments. ALT803 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Cytokine ArmTwo infusions of Natural Killer (NK) cells and ALT803
No Cytokine Arm
Biological
Two infusions of Natural Killer (NK) Cells

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 28 days after beginning treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 28 days after beginning treatment for reporting.

Closest Location

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Sarcoma or one of the other 24 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients who have exhausted other treatment options or who have a cancer that is not responsive to traditional treatments may be eligible for the experimental therapy. show original
Some patients can be eligible for the study even if they have to wait 29 days for treatment show original
In order to be eligible to participate in this study, patients must have (1) histologic confirmation of relapsed and/or refractory hematologic malignancy, (2) locally advanced or metastatic colon/rectal carcinoma, or (3) refractory and/or relapsed soft tissue sarcomas and have failed at least one standard line of therapy. show original
Acute myeloid leukemia
Myelodysplastic syndrome
Acute lymphoblastic leukemia
is a type of leukemia that affects the myeloid cells in the bone marrow show original
Chronic lymphocytic leukemia
Non Hodgkin Lymphoma
Hodgkin lymphoma is a type of cancer that affects the lymphatic system show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get sarcoma a year in the United States?

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Around 55,100 sarcomas are diagnosed each year in the United States. This accounts for almost 2% of all newly diagnosed cancer cases in the world in 2003. The five-year survival rate is 65%; this is among the highest rates ever recorded for any cancer. The average 5-year relative survival rate is 69% when the risk of dying from other causes is accounted for. The overall stage 5 (solid) sarcoma incidence is around 1.2 cases per 100,000 for men and 1.7 for women per year in the United States. The overall age-adjusted incidence rate for solid sarcomas is around 1.8 per 100,000 per year in both women and men in the United States.

Unverified Answer

What are common treatments for sarcoma?

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The study identified the most common chemotherapy agents for sarcomas for which there were no standard protocols for the management of patients. When a sarcoma was found to be locally advanced, the treatment of choice was surgery followed by concurrent chemotherapy.

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What causes sarcoma?

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Though there are many factors which may trigger the development of sarcomas, their exact cause is unknown. However, they may develop from some sort of cancer. Though there are a few specific types that tend to form in certain places, sarcomas may form at any time, anywhere in the body. Although many people survive sarcoma, the disease is rarely cured.\n

Unverified Answer

What is sarcoma?

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Sarcoma, a cancer that forms in a soft, connective or muscle tissue, is one of the most dangerous forms of cancer. Cancer cells form in the cells that make up the tissues. Sarcomas are characterised by tumour cells that are not capable of differentiation. They are very dangerous and can often be difficult to diagnose. It is difficult to know how many people have cancer, the numbers are changing at a dramatic rate. In the UK 2,000 people die of lung cancer every day. Lung cancer can be diagnosed by an X-ray or a CT scan or it can be suspected by screening programmes. Treatment is a combination of medication and surgery, or radiation or chemotherapy.

Unverified Answer

What are the signs of sarcoma?

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Soreness or pain in an extremity often comes as the presenting clinical symptom in sarcoma patients. Other signs of sarcoma include the development of a lump on the skin, fever, skin changes that become painful when touched, or persistent weight loss. Other less common signs of sarcoma include swelling or enlargement of the lymph nodes on the neck, groin, or arms or legs, unexplained weight loss, or signs related to metastatic disease, such as high blood pressure, night sweats, or jaundice. Signs are often the result of an underlying cancer, and the signs themselves frequently are not specific for a particular type of cancer.

Unverified Answer

Can sarcoma be cured?

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There is no cure for sarcoma. The disease is incurable. Survival varies but is better than expected. There is no statistical significance in comparison of various age groups. Survival of sarcoma patients depends on their response to treatment. With proper and timely treatment, many patients can live a full, relatively normal life.

Unverified Answer

Is alt803 safe for people?

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Alt803 is relatively well tolerated and does not result in unacceptable levels of ALT or AST elevations. Alt803 was well tolerated for people receiving doses up to 50mg/kg IM/QXD. Alt803 would be an excellent novel drug candidate for the treatment of people with Hodgkin lymphoma.

Unverified Answer

What does alt803 usually treat?

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Alt803 is almost certainly best suited for use in patients with an inadequate kidney function and/or creatinine clearance (<70 ml/min). It may be more effective when used in combination with gemcitabine as the only agent available for the treatment of pancreatic cancer (when only treatment with Gemcitabine is available). Importantly, Alt803 may be better tolerated when administered concurrently with low dose glucocorticoids as long as these are infused through a central line and do not reach the circulating blood stream; alternatively, dexamethasone can be infused over the course of 24-hours as a subcutaneous injection.

Unverified Answer

Have there been any new discoveries for treating sarcoma?

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There have been several new discoveries. Current evidence suggests that a combination of chemotherapy, radiotherapy and targeted therapy (using agents such as Bortezomib, valsartan and everolimus) has better results than a single agent (i.e. radiation or chemotherapy). The use of targeted therapy and other agents such as the investigational drug-Liposomal Doxorubicin hydrochloride, also known as Adriamycin DPCP, has been shown to be very safe. Further, an increase in the number of patients that are vaccinated against rabies has significantly reduced the number of rabies related deaths caused by rabid animals.

Unverified Answer

What are the latest developments in alt803 for therapeutic use?

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Alt803 is a drug which achieves significant tumor cell deaths even in patients with preexisting tumors of known genetic aberrations. Alt803 causes significant tumor cell apoptosis without triggering a host antitumor immune response. We showed evidence that Alt803 shows a preferential killing of a tumor cell subset specifically infected with oncogenic Ras and/or activated PI3K. Alt803 is well tolerated by humans. It reduces the number of circulating tumor cells and shows promise as an agent to reduce tumor load in advanced disease.

Unverified Answer

What is the latest research for sarcoma?

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The most recent advances in the management have been the development of targeted agents, in particular the monoclonal antibodies. The targeted agents include Rituximab, anti-PD-1 antibody and anti-CD20 antibodies. Immunotherapeutical approaches aimed to deplete B cells using low-dose, schedule-dependent immunosuppressants such as Methotrexate and Cyclophospodone have been added in case of relapse or recurrence in some patients with favorable results for the remission of locally recurrent or metastatic disease. Overall the advances in research in the management of sarcomas have been encouraging with some patients suffering long-term control and complete response by the new therapies.

Unverified Answer
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